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Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

NCT03317496 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-08-29

Study results available
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Summary

This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types.

Conditions

Interventions

DRUG

Avelumab 800 mg in combination with pemetrexed / carboplatin

Avelumab Pemetrexed Carboplatin

DRUG

Avelumab 800 mg in combination with gemcitabine / cisplatin.

Avelumab Gemcitabine Cisplatin

DRUG

Avelumab 1200 mg in combination with pemetrexed/carboplatin

Avelumab Pemetrexed Carboplatin

DRUG

Avelumab 1200 mg in combination with gemcitabine/cisplatin

Avelumab Gemcitabine Cisplatin

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2021-06-07
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Hungary
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03317496 on ClinicalTrials.gov