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

Stopped early · Phase 2

Conditions studied: Non-Small Cell Lung Cancer, Urothelial Cancer

In brief

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.

Key facts

Study ID

NCT03472560

Run by

Pfizer

People needed

61

Starts

2018-05-02

Expected to finish

2023-02-09

Last updated by the study team

2024-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Arizona Oncology Associates- Saguaro Cancer Center — Glendale, Arizona, United States
• Arizona Oncology Associates — Goodyear, Arizona, United States
• Arizona Oncology Associates- Biltmore Cancer Center — Phoenix, Arizona, United States
• Arizona Oncology Associates- Deer Valley Cancer Center — Phoenix, Arizona, United States
• Arizona Oncology Associates- East Valley Cancer Center — Tempe, Arizona, United States
• The Oncology Institute of Hope and Innovation — Glendale, California, United States
• The Oncology Institute of Hope and Innovation — Long Beach, California, United States
• The Oncology Institute of Hope and Innovation — Santa Ana, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• Oncology Hematology Associates — Springfield, Missouri, United States
• Oncology Hematology West, PC dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Oncology Hematology West, PC dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Saint Francis Hospital — Greenville, South Carolina, United States
• Saint Francis Hospital Cancer Center — Greenville, South Carolina, United States
• Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont — Kecskemét, Hungary
• Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs, Hungary
• Tudogyogyintezet Torokbalint — Törökbálint, Hungary
• Azienda Ospedaliero Universitaria Policlinico Umberto I — Roma, Italy
• Cardiologia - Azienda Ospedaliero Universitaria Policlinico Umberto I — Roma, Italy
• Farmacia Azienda Ospedaliero Universitaria Policlinico Umberto I — Roma, Italy
• UOC di Radiologia - Azienda Ospedaliero Universitaria Policlinico Umberto I — Roma, Italy
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie — Warsaw, Masovian Voivodeship, Poland
• Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego w Grudziadzu — Grudziądz, Poland
• Centrum Medyczne Dom Lekarski S.A. — Szczecin, Poland
• Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie — Warsaw, Poland

Full record on ClinicalTrials.gov

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