A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)

NCT03472560 | Terminated Phase 2 Results FDA Drug

• 4 other identifiers: B99910272017-004345-24AVE/ AXI COMBO UCAVE/AXI COMBO UC/NSCLC
• Study Type: interventional
• Target: 61
• Locations: 8 countries
• Sites: 39

Brief Summary

This is a Phase 2 study to evaluate the safety and efficacy of avelumab in combination with axitinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior platinum containing therapy, and in treatment naïve patients with advanced or metastatic urothelial cancer, who are ineligible for cisplatin containing chemotherapy for their advanced disease.

Conditions

Non-Small Cell Lung Cancer; Urothelial Cancer

Keywords

Cancer; non-small cell lung cancer; non small cell lung cancer; NSCLC; lung cancer; urothelial cancer; bladder cancer; Avelumab; Bavencio; Axitinib; Inlyta

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Confirmed Objective Response- Objective Response Rate (ORR)

  ORR: percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) based on investigator's assessment as per Response Evaluation Criteria in Solid Tumours (RECIST version \[v\] 1.1). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after criteria for response was first met. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\]10 millimeter \[mm\]). No new lesions. PR was defined as greater than or equal to (\>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, Progressive Disease.

  Baseline up to 56 months

Secondary Outcomes (17)

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During the On-Treatment Period

  From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer treatment -1 day (maximum up to 56 months)

• Percentage of Participants With Hematology Test Results of Maximum National Cancer Institute; Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade During the On-Treatment Period

  From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer treatment -1 day (maximum up to 56 months)

• Percentage of Participants With Chemistry Test Results of Maximum CTCAE Grade During the On-Treatment Period

  From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer treatment -1 day (maximum up to 56 months)

• Time to Tumor Response (TTR) in Participants With Confirmed CR or PR

  From date of start of treatment until date of first documentation of objective tumor response (maximum up to 56 months)

• Duration of Response in Participants With Confirmed CR or PR

  From date of first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 56 months)

Study Arms (1)

Avelumab in combination with axitinib

EXPERIMENTAL

Avelumab administered at 800 mg IV every two weeks in combination with axitinib, 5 mg PO BID.

Drug: Avelumab (MSB0010718C); Drug: Axitinib (AG-013736)

Interventions

Avelumab (MSB0010718C) DRUG

IV treatment: Avelumab administered at 800 mg IV every two weeks

Also known as: Bavencio

Avelumab in combination with axitinib

Axitinib (AG-013736) DRUG

Oral treatment: Axitinib given 5 mg PO BID

Also known as: Inlyta

Avelumab in combination with axitinib

Eligibility Criteria

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

You may qualify if:

• Non-small cell lung cancer (NSCLC) Cohort: Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic; No activating EGFR mutations, ALK or ROS1 translocations/rearrangements where testing is standard of care; received at least 1 prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC; No more than 2 prior lines of systemic therapy for locally advanced or metastatic disease (If disease progression occurred during or within 6 months after neoadjuvant/adjuvant chemotherapy or radiotherapy-chemotherapy, the regimen is counted as 1 prior treatment regimen towards the allowed limit of prior treatment regimens); Checkpoint inhibitor naïve.
• Urothelial Cancer (UC) Cohort: Histologically or cytologically confirmed diagnosis of transitional cell carcinoma (TCC) of the urothelium (if mixed, more than 50% TCC component) including bladder, urethra, ureters, or renal pelvis that is locally advanced or metastatic; No prior systemic treatment for locally advanced or metastatic disease; Prior neoadjuvant or adjuvant therapy is permitted if disease progression occurred \>12 months after the completion of therapy; Checkpoint inhibitor naïve; Ineligible for receiving cisplatin-containing front-line chemotherapy based at least one of the following criteria: ECOG performance status (PS) 2; Renal dysfunction (defined as creatinine-clearance \<60 ml/min); Grade 2 peripheral neuropathy; Grade 2 hearing loss (hearing loss measured by audiometry of 25 decibels at two contiguous frequencies).
• At least 1 measurable lesion by RECIST v1.1 not previously irradiated.
• Availability of an archival FFPE tumor tissue block from primary diagnosis specimen or metastatic specimen or 15 unstained slides (10 minimum). If an archived sample is not available, a fresh tumor biopsy must be performed.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. For UC patients, ECOG performance 2 is permitted (cisplatin ineligibility criterion)

You may not qualify if:

• Prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-GITR, anti-LAG-3, anti-TIM-3 or anti-CTLA-4 antibody (including ipilimumab).
• Newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids.
• Radiologically documented evidence of major blood vessel invasion or encasement by cancer or intratumor cavitation, regardless of tumor histology.
• Active autoimmune disease (that might deteriorate when receiving an immunostimulatory agent).
• Current use of immunosuppressive medication (except for those listed in protocol).
• Known prior severe hypersensitivity to the investigational products /monoclonal antibodies.
• Known history of immune-mediated colitis, inflammatory bowel disease, immune-mediated pneumonitis, pulmonary fibrosis.
• NCI CTCAE Grade 3 hemorrhage within 28 days prior to study enrollment.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (39)

Arizona Oncology Associates- Saguaro Cancer Center

Glendale, Arizona, 85308, United States

Location

Arizona Oncology Associates

Goodyear, Arizona, 85395, United States

Location

Arizona Oncology Associates- Biltmore Cancer Center

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates- Deer Valley Cancer Center

Phoenix, Arizona, 85027, United States

Location

Arizona Oncology Associates- East Valley Cancer Center

Tempe, Arizona, 85281, United States

Location

The Oncology Institute of Hope and Innovation

Glendale, California, 91204, United States

Location

The Oncology Institute of Hope and Innovation

Long Beach, California, 90805, United States

Location

The Oncology Institute of Hope and Innovation

Santa Ana, California, 92705, United States

Location

The Oncology Institute of Hope and Innovation

Whittier, California, 90602, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

Location

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68114, United States

Location

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Saint Francis Hospital Cancer Center

Greenville, South Carolina, 29607, United States

Location

Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

Kecskemét, H-6000, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, H-7624, Hungary

Location

Tudogyogyintezet Torokbalint

Törökbálint, H-2045, Hungary

Location

Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, 00161, Italy

Location

Cardiologia - Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, 00161, Italy

Location

Farmacia Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, 00161, Italy

Location

UOC di Radiologia - Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, 00161, Italy

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego w Grudziadzu

Grudziądz, 86-300, Poland

Location

Centrum Medyczne Dom Lekarski S.A.

Szczecin, 70-784, Poland

Location

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie

Warsaw, 02-781, Poland

Location

GBUZ of Stavropol Territory "Pyatigorsk Inter-regional Oncology Dispanser"

Pyatigorsk, Stavropol Territory, 357502, Russia

Location

LLC "University clinic of headache"

Moscow, 109028, Russia

Location

Limited Liability Company "VitaMed" (LLC "VitaMed")

Moscow, 121309, Russia

Location

LLC "University Clinic of Headache"

Moscow, 121467, Russia

Location

Limited Liability Company "VitaMed" (LLC "VitaMed")

Moscow, 129515, Russia

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Samsung Medical Center

Gangnam-gu, Seoul, 06351, South Korea

Location

Asan Medical Center

Songpa-gu, Seoul, 05505, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Instituto Catalan de Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellon, 12002, Spain

Location

Chi Mei Hospital, Liouying

Tainan, Liouying District, 73657, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

• Galffy G, Lugowska I, Poddubskaya EV, Cho BC, Ahn MJ, Han JY, Su WC, Hauke RJ, Dyar SH, Lee DH, Serwatowski P, Estelles DL, Holden VR, Kim YJ, Vladimirov V, Horvath Z, Ghose A, Goldman A, di Pietro A, Wang J, Murphy DA, Alhadab A, Laskov M. A phase II open-label trial of avelumab plus axitinib in previously treated non-small-cell lung cancer or treatment-naive, cisplatin-ineligible urothelial cancer. ESMO Open. 2023 Jun;8(3):101173. doi: 10.1016/j.esmoop.2023.101173. Epub 2023 May 2.

  PMID: 37141847 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Lung Neoplasms; Urinary Bladder Neoplasms

Interventions

avelumab; Axitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 21, 2018
• Study Start: May 2, 2018
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: April 9, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

HU (3); TW (2); PL (4); KR (5); US (14); ES (2); RU (5); IT (4)