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Monoclonal Antibodies

Avelumab 800 mg in combination with pemetrexed / carboplatin for Bladder Cancer

Phase 1 & 2

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 from start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 3.5 years approximately)

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new cancer drug, avelumab, when used in combination with chemotherapy. The trial will enroll patients with lung or bladder cancer who have not responded to other treatments.

Eligible Conditions

Bladder Cancer
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 3.5 years approximately)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 3.5 years approximately)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 3.5 years approximately) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment

Phase 1b Lead-in: Number of Participants With Dose-Limiting Toxicities (DLT)

Secondary outcome measures

Absolute Value of Tumor Mutational Burden (TMB) in Tumor Tissue

Duration of Response (DOR) as Per RECIST v 1.1 by Investigator Assessment

Number of Participants With Grade 3 or Higher Laboratory Abnormalities by CTCAE Grade

+9 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group A Cohort A4Experimental Treatment1 Intervention

Cisplatin-eligible urothelial cancer (UC) patients treated with 1200 mg avelumab plus gemcitabine/cisplatin

Group II: Group A Cohort A3Experimental Treatment1 Intervention

Non-squamous non-small cell lung cancer (NSCLC) patients treated with 1200 mg avelumab plus pemetrexed/carboplatin

Group III: Group A Cohort A2Experimental Treatment1 Intervention

Cisplatin-eligible urothelial cancer (UC)patients treated with 800 mg avelumab plus gemcitabine/cisplatin

Group IV: Group A Cohort A1Experimental Treatment1 Intervention

Non-squamous non-small cell lung cancer (NSCLC) patients treated with 800 mg avelumab plus pemetrexed/carboplatin

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Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,919 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,114 Total Patients Enrolled

Frequently Asked Questions

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

What is the main aim of this research project?

"Pfizer, the study sponsor, has identified Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment as the primary outcome over a 24-month time frame. Secondary objectives include Duration of Response (DR), Serum concentrations of avelumab, and Progression-Free Survival (PFS)."

Answered by AI

How widespread is this medical trial, with regard to the number of hospitals involved?

"Numerous medical centres are currently recruiting participants for this clinical trial, amongst them Montefiore Medical Center - Moses Division in Bronx, New york; Stony Brook Cancer Center in Stony Brook, North carolina; and Stony Brook University in Durham, Arizona."

Answered by AI

To what extent has the participant pool for this clinical trial grown?

"Unfortunately, the deadline for this clinical trial has passed. It was first listed on December 21st 2017 and its last update took place on October 13th 2022. However, if you are still searching for other studies to join, there are presently 1442 trials recruiting participants with carcinoma non-small-cell lung cancer and 1505 exploring Avelumab 800 mg in combination with pemetrexed / carboplatin that remain open to enrolment."

Answered by AI

Is the recruitment process for this study still active?

"Unfortunately, this trial is not currently accepting applicants. It was initially posted in December of 2017 and last edited on October 13th 2022. Fortunately there are presently 1442 studies recruiting those with carcinoma non-small cell lung cancer and 1505 trials looking for participants to receive a combination of Avelumab 800 mg alongside pemetrexed/carboplatin treatments."

Answered by AI

What medical conditions can Avelumab 800 mg combined with pemetrexed / carboplatin most effectively address?

"Avelumab 800 mg in combination with pemetrexed/carboplatin is commonly prescribed as an advanced directive treatment. Additionally, it has been found to be effective at treating merkel cell carcinoma, hodgkin disease, and pharmacotherapy patients."

Answered by AI

What other investigations have taken place concerning Avelumab 800 mg in tandem with pemetrexed / carboplatin?

"Avelumab 800 mg in combination with pemetrexed/carboplatin was initially researched at City of Hope Comprehensive Cancer Center back in 1997. This has since spawned 2393 completed studies and 1505 active trials, with many based out of Bronx, New york."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03317496.