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Integrin Antagonist
PF-06940434 + Anti-PD-1 for Advanced Cancers
Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks from the time of enrollment up to 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new drug, PF-06940434, for treating various types of cancer. The trial has two parts: first, researchers will test different doses of the drug to find the best dose, and then they will test the drug in combination with another drug, anti-PD-1.
Who is the study for?
This trial is for adults with certain advanced cancers, including head and neck, kidney, ovarian, stomach, esophageal, lung squamous cell, pancreatic and biliary duct, endometrial melanoma or bladder cancer. Participants must have a confirmed diagnosis and not be suitable for curative intent local therapy. They can't join if they have uncontrolled high blood pressure or active infections like Hepatitis B/C or HIV/AIDS.Check my eligibility
What is being tested?
The study tests PF-06940434 alone and in combination with anti-PD-1 (PF-06801591) to assess safety and effectiveness against various solid tumors. It's an open-label trial that includes dose escalation to find the right amount of drug to use before expanding into larger groups.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions at the injection site, immune-related issues due to anti-PD-1 therapy such as inflammation in organs or skin problems; fatigue; nausea; changes in liver function tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of cancer such as lung, ovarian, or melanoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks from the time of enrollment up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks from the time of enrollment up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Response (DR) for Dose Expansion
Number of Participants With Adverse Events (AEs) According to Seriousness
Number of Participants With Adverse Events (AEs) According to Severity
+4 moreSecondary outcome measures
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591.
+16 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Dose Finding Anti-PD-1 Combination 1Experimental Treatment2 Interventions
Part 1B PF-06940434 plus anti-PD-1
Group II: Dose Expansion, Arm CExperimental Treatment2 Interventions
PF-06940434 with anti-PD-1 (both Q3W)
Group III: Dose Expansion Arm BExperimental Treatment2 Interventions
PF-06940434 with anti-PD-1 in RCC
Group IV: Dose Expansion Arm AExperimental Treatment2 Interventions
PF-06940434 with anti-PD-1 in SCCHN
Group V: Dose EscalationExperimental Treatment1 Intervention
Single Agent Dose Escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06801591
2023
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,788 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,956 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition can be treated with the goal of curing it.My high blood pressure cannot be managed with medication.I do not have any active, uncontrolled infections including Hepatitis B/C or HIV/AIDS.I have been diagnosed with a specific type of cancer such as lung, ovarian, or melanoma.You currently have or had a disease where your immune system attacks your own body.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion, Arm C
- Group 2: Dose Expansion Arm A
- Group 3: Dose Finding Anti-PD-1 Combination 1
- Group 4: Dose Escalation
- Group 5: Dose Expansion Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widespread is this research endeavor?
"These 12 clinics are offering this trial: Monter Cancer Center in Lake Success, Scottsdale Healthcare Hospitals DBA HonorHealth in Scottsdale and University of Maryland Greenebaum Comprehensive Cancer Center in Baltimore. Additionally, there are 9 other medical centres providing access to the study."
Answered by AI
Has PF-06940434 been given the regulatory green light by the FDA?
"PF-06940434 has yet to be exposed to large scale trials, so it was given a safety rating of 1 on our index due to lack of evidence indicating efficacy and limited data regarding its impact."
Answered by AI
Are there still opportunities for individuals to participate in this clinical exploration?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, which was launched on November 13th 2019 is now seeking participants. 122 individuals are required to be enrolled in the study from 12 different sites."
Answered by AI
What is the enrolment limit of participants for this trial?
"Affirmative, the clinical trial is actively recruiting - as indicated by information hosted on clinicaltrials.gov. The initial posting date was November 13th 2019 and it has been amended most recently on November 17th 2022; this research endeavour seeks 122 participants across 12 medical facilities."
Answered by AI
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