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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 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 67 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03317496
The ClinicalTrials.gov registry entry for NCT03317496 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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