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Monoclonal Antibodies

Continued Avelumab-Based Therapy for Cancer

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Female participants who are pregnant or breastfeeding.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is to provide continued treatment and safety follow-up for eligible participants who are benefiting from the study intervention in the Avelumab parent studies.

Who is the study for?
This trial is for patients benefiting from Avelumab in previous Pfizer studies, who have solid tumors or specific cancers like lung, bladder, or ovarian cancer. They must follow reproductive guidelines and be able to stick with the study plan. Pregnant or breastfeeding women can't participate.
What is being tested?
The trial continues access to treatments such as Pemetrexed and Avelumab for those already seeing benefits. It also includes safety monitoring and survival tracking for various drugs that were part of earlier Avelumab studies.
What are the potential side effects?
Possible side effects include immune system reactions, infusion-related symptoms, fatigue, nausea, potential blood clots or bleeding issues due to Talazoparib and high blood pressure from Axitinib.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Endocrine disorders
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
General disorders and administration site conditions
6%
Investigations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Infections and infestations
6%
Immune system disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups
Experimental Treatment
Group I: Arm 8Experimental Treatment2 Interventions
Avelumab in combination with Talazoparib as specified by sub-study B9991032C.
Group II: Arm 7Experimental Treatment2 Interventions
Avelumab in combination with Axitinib as specified by sub-study B9991027C.
Group III: Arm 6Experimental Treatment2 Interventions
Avelumab in combination with Talazoparib as specified by sub-study B9991025C.
Group IV: Arm 5Experimental Treatment2 Interventions
Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C
Group V: Arm 4Experimental Treatment1 Intervention
Avelumab monotherapy as specified by sub-study protocol B9991009C
Group VI: Arm 3Experimental Treatment2 Interventions
Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C
Group VII: Arm 2Experimental Treatment4 Interventions
Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
Group VIII: Arm 1Experimental Treatment1 Intervention
Avelumab monotherapy as specified by sub-study protocol B9991001C
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5550
Avelumab
2017
Completed Phase 2
~2440
Axitinib
2020
Completed Phase 2
~3050
Talazoparib
2021
Completed Phase 2
~2810
Utomilumab
2017
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,114 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,970 Total Patients Enrolled

Media Library

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~22 spots leftby Sep 2026
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