TerminatedPhase 2NCT03472560

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

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.

Checked against the public recordLast updated Apr 9, 2024 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations39
SponsorPfizer
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Pfizer
Interventions being studied
Drug: Avelumab (MSB0010718C); Drug: Axitinib (AG-013736)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Criteria: * 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Arizona Oncology Associates- Saguaro Cancer CenterGlendale, Arizona
  • Arizona Oncology AssociatesGoodyear, Arizona
  • Arizona Oncology Associates- Biltmore Cancer CenterPhoenix, Arizona
  • Arizona Oncology Associates- Deer Valley Cancer CenterPhoenix, Arizona
  • Arizona Oncology Associates- East Valley Cancer CenterTempe, Arizona
  • The Oncology Institute of Hope and InnovationGlendale, California
  • The Oncology Institute of Hope and InnovationLong Beach, California
  • The Oncology Institute of Hope and InnovationSanta Ana, California
  • The Oncology Institute of Hope and InnovationWhittier, California
  • Oncology Hematology AssociatesSpringfield, Missouri
  • Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmaha, Nebraska
  • Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmaha, Nebraska

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 9, 2024. Always confirm current availability with the study team.

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