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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events leading to permanent discontinuation of study intervention
Number serious adverse events reported for all participants

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Immune system disorders
6%
Endocrine disorders
6%
Cardiac disorders
6%
Nervous system disorders
6%
Infections and infestations
6%
Investigations
6%
Metabolism and nutrition 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

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
~5250
Avelumab
2018
Completed Phase 2
~2450
Axitinib
2020
Completed Phase 2
~3050
Talazoparib
2021
Completed Phase 2
~2770
Utomilumab
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,379 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,493 Total Patients Enrolled

Media Library

Bladder Cancer Research Study Groups: Arm 7, Arm 1, Arm 3, Arm 4, Arm 8, Arm 2, Arm 5, Arm 6

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients who want to participate in this trial?

"That is accurate. If you refer to the information available on clinicaltrials.gov, you will see that this trial is still recruiting patients. The original posting dates back to September 29th 2021 with the most recent edit happening on October 24th of this year. They are currently looking for 262 participants across 15 different locations."

Answered by AI

For what purpose is Avelumab most commonly prescribed?

"Avelumab is a treatment option for patients with the brca1 gene, merkel cell carcinoma, and certain forms of pharmacotherapy."

Answered by AI

How many hospitals are participating in this research project?

"This trial has 15 enrolling patients at locations such as UCLA Hematology/Oncology - Administrative Office in Los Angeles, UCLA Hematology/Oncology in New york, and Memorial Sloan Kettering Cancer Center 53rd street. in Springdale, among others."

Answered by AI

How many human subjects are being observed in this research project?

"That is correct. The clinicaltrials.gov website shows that this trial, which was published on September 29th 2021, is looking for 262 patients from 15 hospitals or medical practices."

Answered by AI

Is Avelumab a common ingredient in other research?

"Avelumab was first investigated in 2005 by Hematology-Oncology Associates of Illinois. As of now, there have been 443 completed studies with 433 more currently underway; many of these active trials are based in Los Angeles."

Answered by AI

Has Avelumab received federal approval for medical use?

"Avelumab's safety is supported by some efficacy data and multiple rounds of safe testing, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
The University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
2021. "Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05059522.
All > Inlyta
~29 spots leftby Sep 2026
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