Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

NCT04628767 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: NCI-2020-09850EA8192U10CA180820
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 258

Brief Summary

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)

  Disease progression prior to surgery or omission of surgery due to unresectable tumors, muscle-invasive cancer or disease recurring outside of the bladder, urethra, or contralateral upper tract are considered as events for EFS.

  From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years

• Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C)

  Will assess pathologic complete response at surgery (pCR, pT0N0/Nx) by local pathology review. Patients who drop out prior to surgery or who have unknown response status will be considered as non-responders.

  At surgery

Secondary Outcomes (7)

• pCR (Cisplatin-eligible cohort: Arms A and B)

  Up to 5 years

• EFS (cisplatin-ineligible cohort: Arm C)

  From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years

• Overall survival (OS) (All Patients)

  From registration/randomization to death from any cause, assessed up to 5 years

• Urothelial cancer-free survival or disease-free survival (All Patients)

  From the date of surgery to the earlier of a return of upper tract urothelial cancer (UTUC) or death from any cause, assessed up to 5 years

• Cancer-specific survival (All Patients)

  From registration/randomization to death due to cancer; deaths due to other causes will be counted as competing events, assessed up to 5 years

Study Arms (3)

Arm A (durvalumab, chemotherapy)

EXPERIMENTAL

Patients receive durvalumab IV over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Doxorubicin Hydrochloride; Biological: Durvalumab; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Biological: Pegfilgrastim; Procedure: Therapeutic Conventional Surgery; Drug: Vinblastine Sulfate

Arm B (chemotherapy)

ACTIVE COMPARATOR

Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Doxorubicin Hydrochloride; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Biological: Pegfilgrastim; Procedure: Therapeutic Conventional Surgery; Drug: Vinblastine Sulfate

Arm C (durvalumab, gemcitabine hydrochloride)

EXPERIMENTAL

Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Imaging; Procedure: Therapeutic Conventional Surgery

Interventions

Biopsy Procedure PROCEDURE

Undergo tissue biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy); Arm C (durvalumab, gemcitabine hydrochloride)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy); Arm C (durvalumab, gemcitabine hydrochloride)

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy)

Doxorubicin Hydrochloride DRUG

Given Iv

Also known as: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, FI106, hydroxydaunorubicin, Rubex

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy); Arm C (durvalumab, gemcitabine hydrochloride)

Durvalumab BIOLOGICAL

Given IV

Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736, MEDI4736

Arm A (durvalumab, chemotherapy); Arm C (durvalumab, gemcitabine hydrochloride)

Gemcitabine Hydrochloride DRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY 188011, LY-188011, LY188011

Arm C (durvalumab, gemcitabine hydrochloride)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy); Arm C (durvalumab, gemcitabine hydrochloride)

Methotrexate DRUG

Given IV

Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Jylamvo, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy)

Pegfilgrastim BIOLOGICAL

Given via injection

Also known as: Dulastin, Filgrastim SD-01, filgrastim-SD/01, Fulphila, Fylnetra, G-Lasta, HSP-130, Jinyouli, Neulasta, Neulastim, Neupopeg, Nyvepria, PEG-filgrastim, Pegcyte, Pegfilgrastim Biosimilar HSP-130, Pegfilgrastim Biosimilar Nyvepria, Pegfilgrastim Biosimilar Pegcyte, Pegfilgrastim Biosimilar PF-06881894, Pegfilgrastim Biosimilar Udenyca, Pegfilgrastim Biosimilar Ziextenzo, Pegfilgrastim-apgf, Pegfilgrastim-bmez, Pegfilgrastim-cbqv, Pegfilgrastim-fpgk, Pegfilgrastim-jmdb, Pegfilgrastim-pbbk, Pegylated G-CSF, Pegylated GCSF, Pegylated Granulocyte Colony Stimulating Factor, PF-06881894, SD-01, SD-01 sustained duration G-CSF, Stimufend, Tripegfilgrastim, Udenyca, Ziextenzo

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy)

Vinblastine Sulfate DRUG

Given Iv

Also known as: 29060 LE, 29060-LE, Exal, Velban, Velbe, Velsar, VINCALEUKOBLASTINE

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

Arm A (durvalumab, chemotherapy); Arm B (chemotherapy); Arm C (durvalumab, gemcitabine hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEP 1 REGISTRATION AND RANDOMIZATION
• Patients must be \>= 18 years of age
• Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
• Patient must have a diagnosis of high grade upper tract urothelial carcinoma expected within 14 weeks (98 days) prior to registration/randomization with one of the following:
• Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or
• Tumor directly visualized during upper urinary tract endoscopy
• High grade cytology and clinically estimated invasive upper urinary tract mass on cross-sectional imaging (e.g., including presence of tumor-related hydronephrosis) or tumor directly visualized during upper urinary tract endoscopy
• NOTE: Universal histologic testing of UTUC with additional studies, such as immunohistochemistry or microsatellite instability, is strongly recommended to identify patients with high probability of Lynch-related or other germline mutation related cancers whom clinicians should refer for genetic counseling and germline testing (this is not required for eligibility)
• Due to the anatomy of upper urinary tract and lack of muscularis propria, pathologic evidence of cT2 on biopsy is usually not possible
• Leukocytes \>= 3,000/mcL (obtained =\< 14 days prior to registration/randomization)
• Platelets \>= 100,000/mcL (obtained =\< 14 days prior to registration/randomization)
• Total bilirubin =\< 1.2 mg/dL (or ≤ 2 mg/dLfor patients with Gilbert's disease)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2 x institutional ULN (obtained =\< 14 days prior to registration/randomization)
• Hemoglobin (Hgb) \>= 9 g/dL (obtained =\< 14 days prior to registration/randomization)
• NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator

You may not qualify if:

• Patients must not have any component of small cell/neuroendocrine carcinoma. Other histologic subtypes (variants) are permitted provided the half or predominant (\>= 50%) subtype is conventional urothelial carcinoma
• Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment
• Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (\>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings \>=1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) or other imaging or other criteria can be eligible based on investigator discretion).
• NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scan to evaluate for bone metastasis at the discretion of local provider.
• Patient must meet below criteria for prior/current malignancy history:
• Non-urothelial cancer malignancy history:
• Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =\< Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat
• NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Urothelial cancer malignancy history:
• Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:
• T0, Ta or Tis at any time
• T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy \[e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)\]. Prior immune checkpoint inhibitor is not allowed.
• Patient with history of \>= pT4b, N+, and/or M1 UC is not eligible.
• NOTE: Patients in whom concomitant or prior bladder/urethra predominant (\>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (\< cT1 N0) are eligible regardless of time elapsed

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (258)

Kingman Regional Medical Center

Kingman, Arizona, 86401, United States

RECRUITING

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

SUSPENDED

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

ACTIVE NOT RECRUITING

Sutter Auburn Faith Hospital

Auburn, California, 95602, United States

ACTIVE NOT RECRUITING

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

ACTIVE NOT RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

Palo Alto Medical Foundation-Fremont

Fremont, California, 94538, United States

ACTIVE NOT RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Memorial Medical Center

Modesto, California, 95355, United States

ACTIVE NOT RECRUITING

Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040, United States

ACTIVE NOT RECRUITING

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

ACTIVE NOT RECRUITING

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

RECRUITING

Sutter Roseville Medical Center

Roseville, California, 95661, United States

ACTIVE NOT RECRUITING

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

ACTIVE NOT RECRUITING

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

RECRUITING

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

ACTIVE NOT RECRUITING

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065, United States

ACTIVE NOT RECRUITING

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

ACTIVE NOT RECRUITING

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086, United States

ACTIVE NOT RECRUITING

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589, United States

ACTIVE NOT RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth - Cherry Creek

Denver, Colorado, 80206, United States

RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States

RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, 80631, United States

RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

RECRUITING

UCHealth Lone Tree Health Center

Lone Tree, Colorado, 80124, United States

RECRUITING

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

ACTIVE NOT RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

RECRUITING

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

SUSPENDED

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States

RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

ACTIVE NOT RECRUITING

Loyola Center for Health at Burr Ridge

Burr Ridge, Illinois, 60527, United States

ACTIVE NOT RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

ACTIVE NOT RECRUITING

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

SUSPENDED

SIH Cancer Institute

Carterville, Illinois, 62918, United States

RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

ACTIVE NOT RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

SUSPENDED

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

RECRUITING

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014, United States

RECRUITING

Carle at The Riverfront

Danville, Illinois, 61832, United States

RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

SUSPENDED

Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States

ACTIVE NOT RECRUITING

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

RECRUITING

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

RECRUITING

Advocate Sherman Hospital

Elgin, Illinois, 60123, United States

RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

ACTIVE NOT RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

ACTIVE NOT RECRUITING

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

SUSPENDED

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429, United States

RECRUITING

Loyola Medicine Homer Glen

Homer Glen, Illinois, 60491, United States

ACTIVE NOT RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

ACTIVE NOT RECRUITING

AMG Libertyville - Oncology

Libertyville, Illinois, 60048, United States

RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

ACTIVE NOT RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

ACTIVE NOT RECRUITING

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois, 60160, United States

ACTIVE NOT RECRUITING

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States

SUSPENDED

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699, United States

RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

ACTIVE NOT RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

ACTIVE NOT RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

ACTIVE NOT RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

SUSPENDED

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

ACTIVE NOT RECRUITING

Valley Radiation Oncology

Peru, Illinois, 61354, United States

SUSPENDED

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

ACTIVE NOT RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Clinic

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

SUSPENDED

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

ACTIVE NOT RECRUITING

Reid Health

Richmond, Indiana, 47374, United States

ACTIVE NOT RECRUITING

Mary Greeley Medical Center

Ames, Iowa, 50010, United States

ACTIVE NOT RECRUITING

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

ACTIVE NOT RECRUITING

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, 52722, United States

RECRUITING

McFarland Clinic - Boone

Boone, Iowa, 50036, United States

ACTIVE NOT RECRUITING

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501, United States

ACTIVE NOT RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129, United States

ACTIVE NOT RECRUITING

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158, United States

ACTIVE NOT RECRUITING

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846, United States

SUSPENDED

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530, United States

SUSPENDED

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Mary Bird Perkins Cancer Center - Metairie

Metairie, Louisiana, 70002, United States

RECRUITING

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

RECRUITING

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Harold Alfond Center for Cancer Care

Augusta, Maine, 04330, United States

RECRUITING

MaineHealth Maine Medical Center - Biddeford

Biddeford, Maine, 04005, United States

SUSPENDED

MaineHealth Cancer Care and IV Therapy - Sanford

Sanford, Maine, 04073, United States

RECRUITING

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States

RECRUITING

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, 04106, United States

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States

RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States

RECRUITING

Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States

RECRUITING

Chelsea Hospital

Chelsea, Michigan, 48118, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States

RECRUITING

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States

RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

SUSPENDED

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

RECRUITING

Hurley Medical Center

Flint, Michigan, 48503, United States

RECRUITING

Hope Cancer Clinic

Livonia, Michigan, 48154, United States

SUSPENDED

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

RECRUITING

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States

RECRUITING

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341, United States

RECRUITING

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341, United States

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

RECRUITING

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604, United States

SUSPENDED

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764, United States

RECRUITING

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661, United States

SUSPENDED

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

RECRUITING

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

SUSPENDED

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337, United States

SUSPENDED

Cambridge Medical Center

Cambridge, Minnesota, 55008, United States

SUSPENDED

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

SUSPENDED

Unity Hospital

Fridley, Minnesota, 55432, United States

ACTIVE NOT RECRUITING

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369, United States

SUSPENDED

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

SUSPENDED

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

SUSPENDED

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

SUSPENDED

Health Partners Inc

Minneapolis, Minnesota, 55454, United States

SUSPENDED

Monticello Cancer Center

Monticello, Minnesota, 55362, United States

SUSPENDED

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

SUSPENDED

Fairview Northland Medical Center

Princeton, Minnesota, 55371, United States

SUSPENDED

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

SUSPENDED

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

United Hospital

Saint Paul, Minnesota, 55102, United States

SUSPENDED

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

SUSPENDED

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

RECRUITING

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

SUSPENDED

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

SUSPENDED

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

SUSPENDED

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092, United States

SUSPENDED

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, 63011, United States

SUSPENDED

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

SUSPENDED

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, 63703, United States

SUSPENDED

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

RECRUITING

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

SUSPENDED

Freeman Health System

Joplin, Missouri, 64804, United States

SUSPENDED

Mercy Hospital Joplin

Joplin, Missouri, 64804, United States

SUSPENDED

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

SUSPENDED

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States

SUSPENDED

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

SUSPENDED

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

SUSPENDED

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

SUSPENDED

Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109, United States

SUSPENDED

Mercy Hospital South

St Louis, Missouri, 63128, United States

RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

RECRUITING

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

RECRUITING

Mercy Hospital Washington

Washington, Missouri, 63090, United States

SUSPENDED

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052, United States

RECRUITING

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102, United States

RECRUITING

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

COMPLETED

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

Community Medical Center

Toms River, New Jersey, 08755, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

ACTIVE NOT RECRUITING

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328, United States

RECRUITING

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

RECRUITING

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

ACTIVE NOT RECRUITING

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459, United States

ACTIVE NOT RECRUITING

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

RECRUITING

Miami Valley Hospital

Dayton, Ohio, 45409, United States

RECRUITING

Premier Blood and Cancer Center

Dayton, Ohio, 45409, United States

RECRUITING

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415, United States

ACTIVE NOT RECRUITING

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

RECRUITING

Armes Family Cancer Center

Findlay, Ohio, 45840, United States

ACTIVE NOT RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

RECRUITING

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005, United States

ACTIVE NOT RECRUITING

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331, United States

RECRUITING

Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

ACTIVE NOT RECRUITING

Kettering Medical Center

Kettering, Ohio, 45429, United States

ACTIVE NOT RECRUITING

Springfield Regional Cancer Center

Springfield, Ohio, 45504, United States

SUSPENDED

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

RECRUITING

Upper Valley Medical Center

Troy, Ohio, 45373, United States

RECRUITING

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

SUSPENDED

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States

RECRUITING

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

RECRUITING

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146, United States

RECRUITING

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

RECRUITING

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243, United States

RECRUITING

UPMC Cancer Center-Washington

Washington, Pennsylvania, 15301, United States

RECRUITING

Reading Hospital

West Reading, Pennsylvania, 19611, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

ACTIVE NOT RECRUITING

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

RECRUITING

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237, United States

SUSPENDED

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

RECRUITING

West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States

RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

RECRUITING

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105, United States

RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

RECRUITING

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022, United States

RECRUITING

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

RECRUITING

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

RECRUITING

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States

RECRUITING

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143, United States

RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

RECRUITING

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209, United States

RECRUITING

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

RECRUITING

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

RECRUITING

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States

RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017, United States

SUSPENDED

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

RECRUITING

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

RECRUITING

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406, United States

RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

RECRUITING

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States

RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

RECRUITING

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

RECRUITING

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

RECRUITING

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

RECRUITING

ThedaCare Cancer Care - Waupaca

Waupaca, Wisconsin, 54981, United States

RECRUITING

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States

RECRUITING

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

RECRUITING

MeSH Terms

Interventions

Biopsy; Specimen Handling; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Doxorubicin; durvalumab; Immunoglobulin G; Disulfides; Gemcitabine; Magnetic Resonance Spectroscopy; Methotrexate; merphos; pegfilgrastim; pegylated granulocyte colony-stimulating factor; Vinblastine

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Hydrogen Sulfide; Sulfur Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Spectrum Analysis; Chemistry Techniques, Analytical; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Jean H Hoffman-Censits

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 16, 2020
• Study Start: November 12, 2021
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (258)