Status:
TERMINATED
A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)
Lead Sponsor:
Pfizer
Conditions:
Non-Small Cell Lung Cancer
Urothelial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lea...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03472560
Start Date
May 2 2018
End Date
February 9 2023
Last Update
April 9 2024
Active Locations (39)
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1
Arizona Oncology Associates- Saguaro Cancer Center
Glendale, Arizona, United States, 85308
2
Arizona Oncology Associates
Goodyear, Arizona, United States, 85395
3
Arizona Oncology Associates- Biltmore Cancer Center
Phoenix, Arizona, United States, 85016
4
Arizona Oncology Associates- Deer Valley Cancer Center
Phoenix, Arizona, United States, 85027