What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, such as chemotherapy, radiation therapy, and immunotherapy (including anti-PD-1 therapies), have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infection due to lowered blood cell counts. Radiation therapy often leads to esophagitis, causing pain and difficulty swallowing, as well as fatigue and skin changes. Immunotherapy, particularly anti-PD-1 therapies, can result in immune-related adverse events such as colitis, pneumonitis, hepatitis, and endocrinopathies. These treatments aim to manage the cancer but come with significant side effects that need to be monitored and managed by healthcare providers.

What prior FDA approvals exist?

Pembrolizumab (Keytruda), an anti-PD-1 monoclonal antibody, has been approved by the FDA for the treatment of esophageal cancer, particularly for patients with advanced or metastatic esophageal squamous cell carcinoma. This approval is based on its demonstrated efficacy in improving overall survival and progression-free survival. Other similar immune checkpoint inhibitors, such as nivolumab (Opdivo), have also been approved for esophageal cancer, targeting the PD-1 pathway to enhance the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to PF-06940434 for esophageal cancer patients include camrelizumab, which showed improved survival and progression-free survival in the ESCORT-1st trial, and nivolumab, which demonstrated efficacy and safety in the ATTRACTION-3 trial. Both are immunotherapies that have shown potential benefits in clinical trials for esophageal cancer.

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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

Must not have

Hypertension that cannot be controlled by medications.

Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks from the time of enrollment up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called PF-06940434 that blocks a protein to stop cancer cells from growing. It targets patients with various types of cancers who may not respond well to standard treatments. The study aims to find the best dose and check the safety of the drug.

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.

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.

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 below

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I have been diagnosed with a specific type of cancer such as lung, ovarian, or melanoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure cannot be managed with medication.

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I do not have any active, uncontrolled infections including Hepatitis B/C or HIV/AIDS.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks from the time of enrollment up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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.

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for esophageal cancer include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy drugs, such as cisplatin and fluorouracil, work by damaging the DNA of cancer cells, thereby inhibiting their ability to divide and grow. Immunotherapy, including agents like pembrolizumab and nivolumab, enhances the body's immune response against cancer cells by targeting immune checkpoints like PD-1/PD-L1. Targeted therapies, such as the Integrin alpha-V/beta-8 Antagonist PF-06940434, focus on specific molecules involved in cancer progression, aiming to disrupt cancer cell signaling and interactions with the tumor microenvironment. These treatments are crucial for esophageal cancer patients as they offer multiple avenues to control tumor growth, improve survival rates, and potentially reduce side effects compared to traditional therapies.

Integrin expression in esophageal squamous cell carcinoma: loss of the physiological integrin expression pattern correlates with disease progression.