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AhR Inhibitor

BAY 2416964 + Pembrolizumab for Cancer

Phase 1

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be ≥18 years of age inclusive, at the time of signing the informed consent

Participants with histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease known to confer clinically meaningful benefit, or are intolerant to treatment, or refuse standard treatment

Must not have

History of pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease

Severe infections (CTCAE v.5 Grade ≥ 3) within 4 weeks before the first study intervention administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of cycle 2 (-7 days, each cycle is 21 days), cycle 4 (-7 days) and at the end of every third cycle (-7 days) from cycle 5 onwards

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, BAY 2416964, combined with pembrolizumab to treat advanced cancers like head and neck, lung, and bladder cancer. BAY 2416964 helps the immune system fight cancer by blocking a protein that hinders immune cells. The study aims to find the safest and most effective dose of this combination.

Who is the study for?

Adults with advanced solid tumors, including specific types of lung, bladder, and head and neck cancer that have worsened after standard treatments or who cannot tolerate such treatments. Participants must be over 18 years old with an ECOG performance status of 0 to 1 (indicating they are fully active or restricted in physically strenuous activity but ambulatory).

What is being tested?

The trial is testing BAY 2416964 combined with pembrolizumab for safety, tolerability, the maximum safe dose level, how it affects the body and its effectiveness against cancer. The study has two parts: dose escalation to find the right dose and dose expansion using this determined dose.

What are the potential side effects?

Potential side effects may include immune-related reactions due to pembrolizumab's action on the immune system as well as any typical drug-related adverse events like nausea, fatigue or allergic reactions. Specific side effects related to BAY 2416964 are not detailed but will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My advanced cancer has not responded to, or I cannot tolerate, all known beneficial treatments.

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My cancer has worsened despite treatment with specific immune therapy.

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My cancer is either lung, head and neck, or bladder cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have or had lung inflammation that needed steroids.

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I have not had a severe infection in the last 4 weeks.

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I have an immune system disorder or am on medication that weakens my immune system.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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My cancer has spread to my brain or the lining around my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 2 (-7 days, each cycle is 21 days), cycle 4 (-7 days) and at the end of every third cycle (-7 days) from cycle 5 onwards

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of cycle 2 (-7 days, each cycle is 21 days), cycle 4 (-7 days) and at the end of every third cycle (-7 days) from cycle 5 onwards

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 2 (-7 days, each cycle is 21 days), cycle 4 (-7 days) and at the end of every third cycle (-7 days) from cycle 5 onwards for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2416964

The incidence of TEAEs including TESAEs

Secondary study objectives

Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose expansion of BAY2416964 in tumor type specific cohortExperimental Treatment2 Interventions

To determine the RP2D of BAY2416964 in combination therapy with pembrolizumab. Participants will be enrolled in up to 3 tumor type-specific cohorts including relapsed/refractory non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and urothelial cancer.

Group II: Dose escalation of BAY2416964Experimental Treatment2 Interventions

Six dose levels of BAY 2416964 (as determined in the first in human mono-therapy study of BAY2416964) are planned in combination with standard dose Pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

BAY2416964

2019

Completed Phase 1

~80