A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer

NCT03498196 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: H-41207
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

This is a pilot study of avelumab in patients with non-metastatic, muscle invasive bladder cancer who are eligible for radical cystectomy (RC), but are ineligible for cisplatin based neoadjuvant therapy. The target recruitment is 10 evaluable patients for this window of opportunity study. Pre- and post-treatment tumor samples from transurethral resection of the bladder tumor and RC will be used for study endpoints.

Conditions

Bladder Cancer; Metastatic Bladder Cancer; Invasive Bladder Cancer

Keywords

muscle invasive bladder cancer; non-muscle invasive bladder cancer; radical cystectomy; monoclonal antibodies; Avelumab; Invasive Resectable disease; MIBC; NMIBC; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change in T Cell Subpopulations

  The change in T cell subpopulations (CD8, CD4 and/or CD3) in tumor samples will be collected from FFPE tissue. FFPE tissue from the pre-study time point refers to tissue from the TURBT. FFPE tissue from the 2-3 week post-op time point refers to FFPE tissue from the RC

  pre-study time and 2-3 week post-operation

Secondary Outcomes (3)

• Pathological Response Rate

  pre-study time and 2-3 week post-operation

• 2 Year Disease Free Survival (DFS)

  2 years after radical cystectomy

• Rate of High Grade(Grade 3-4) Adverse Event

  90 days post operation

Study Arms (1)

Avelumab

EXPERIMENTAL

Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days.

Drug: Avelumab

Interventions

Avelumab DRUG

avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.

Also known as: MSB0010718C

Avelumab

Eligibility Criteria

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

You may qualify if:

• Have undergone TURBT showing newly diagnosed muscle invasive UCB (mixed histology is allowed if the predominant histology is UCC) within 6 weeks prior to cycle 1, day 1 of treatment.
• No prior systemic treatment for muscle invasive UCB
• Clinical T2-T4a disease
• No evidence of clinically positive lymph nodes or distant metastasis on computed tomography (CT) scans of chest and CT or magnetic resonance imaging (MRI) studies of the abdomen/pelvis. Imaging must be within 90 days of registration.
• Male or female subjects aged ≥ 18 years old.
• Must have adequate kidney, liver, and bone marrow function within 30 days of registration, as follows:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• platelet count ≥ 100 × 109/L
• hemoglobin ≥ 9 g/dL (may have been transfused)
• Total bilirubin level ≤ 1.5 × ULN
• AST and ALT levels ≤ 2.5 × ULN
• Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula
• Negative serum or urine pregnancy test at screening for women of childbearing potential (WOCBP), within 30 days of registration.
• Both male and female subjects must agree to use highly effective contraception (see Section 6.1 Table 8) while receiving avelumab and for at least 60 days after last avelumab treatment if the risk of conception exists.
• Female patients must agree to inform study coordinator or investigator immediately if they think they have become pregnant during the study.

You may not qualify if:

• Patients must not have any of the following:
• IMMUNOSUPRESSANTS: Current use of immunosuppressive medication or within 4 weeks of C1D1, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
• AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. Patients with type I diabetes or hypo- or hyperthyroidism should be on stable doses of medications for participation.
• ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation.
• INFECTIONS: Active infection requiring systemic therapy.
• HIV/AIDS: Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
• HEPATITIS: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
• VACCINATION: Vaccinate within 4 weeks of the first dose of avelumab and while on study drug is prohibited except for administration of inactivated vaccines
• HYPERSENSITIIVTY TO STUDY DRUG: Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)
• CARDIOVASCULAR DISEASE: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
• Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
• Relapsed MIBC (all patients participating in the study should be newly diagnosed)
• Concomitant UCC outside the bladder (e.g., ureter, urethra or renal pelvis)
• Underlying immune disorder (e.g., combined variable immunodeficiency syndrome)
• Erythropoietin receptor agonists within 30 days prior to enrollment.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Pfizer: collaborator

Study Sites (3)

Baylor College of Medicine Medical Center - McNair Campus

Houston, Texas, 77030, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Michael E. DeBakey Veteran Affairs Medical Center

Houston, Texas, 77030, United States

Location

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Related Links

• SITC 2016: Immune Checkpoint Inhibitors Shrink Tumors in Some Patients With Metastatic Bladder Cancer
• Cardiac Complications in Patients Receiving Combination Checkpoint Inhibitors Are Rare but Can Be Fatal

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

avelumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Jennifer M. Taylor, MD, MPH
• Organization: Baylor College of Medicine

Jennifer.Taylor@bcm.edu

713-797-7670

Study Officials

• Jennifer M. Taylor, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 13, 2018
• Study Start: December 14, 2018
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Locations

US (3)