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NCT03317496 · ClinicalTrials.gov registry record · Phase 1
Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT03317496: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT03317496 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03317496, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
DLTs=occurrence of any AEs attributable to study treatment in first 2 treatment cycles:Hematologic: grade(G)4 neutropenia lasting \>7days;febrile neutropenia with body temperature \>=38 degree Celsius for \>1hour; G\>=3 neutropenic infection(absolute neutrophil count \<1.0\*10\^9/L),G\>=3 thrombocytopenia (platelet count\<50.0-25.0\*10\^9/L)with bleeding;G4 thrombocytopenia(PC\<25.0\*10\^9/L),G4 anemia(life-threatening).Non-hematologic: any G4 toxicities;G3 toxicities persisting for \>3days desp
Interventions
- DRUG Avelumab 800 mg in combination with pemetrexed / carboplatin
- DRUG Avelumab 800 mg in combination with gemcitabine / cisplatin.
- DRUG Avelumab 1200 mg in combination with pemetrexed/carboplatin
- DRUG Avelumab 1200 mg in combination with gemcitabine/cisplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2017-12-21 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 1 |
Why NCT03317496 stopped before completion
NCT03317496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 4 interventions - of which Avelumab 800 mg in combination with pemetrexed / carboplatin is the first listed.
NCT03317496 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03317496 about?
NCT03317496 is a clinical study titled "Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies". 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 carbopla...
What is the current status of trial NCT03317496?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2017-12-21. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT03317496?
The interventions under investigation include: Avelumab 800 mg in combination with pemetrexed / carboplatin (DRUG), Avelumab 800 mg in combination with gemcitabine / cisplatin. (DRUG), Avelumab 1200 mg in combination with pemetrexed/carboplatin (DRUG), Avelumab 1200 mg in combination with gemcitabine/cisplatin (DRUG).
Who is sponsoring clinical trial NCT03317496?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03317496's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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