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BAY3375968 + Pembrolizumab for Advanced Cancer
Study Summary
This trial is studying a new way to treat people with advanced solid tumors by using immunotherapy with PD-1/PD-L1 inhibitors and an antibody that binds to a protein called CCR8.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I've tried or can't tolerate all known beneficial treatments.My cancer originated in my brain or spinal cord.I have been treated for an autoimmune disease in the last 2 years.I have not had major surgery in the last 4 weeks.I have another cancer that is getting worse or was treated in the last 3 years.I have had lung inflammation not caused by infection that needed steroids.I have not had lung radiation over 30 Gy in the last 6 months.I have an immune system disorder or am on high-dose steroids.I have been diagnosed with TNBC, NSCLC, HNSCC, or melanoma.My lung cancer diagnosis was confirmed through lab tests.I am HIV-positive with a history of Kaposi sarcoma or Castleman Disease.My cancer is advanced or has spread and confirmed by lab tests.I have a history of severe heart failure.I have been treated with a CCR8 depleting antibody before.My kidney and liver are working well.I have new or worsening brain metastases or leptomeningeal disease.I am able to understand and sign the consent form.I have no lasting side effects from cancer treatment, except for hair loss or skin color changes.I stopped a previous cancer treatment due to severe side effects.I have a serious illness or had an organ transplant that needs ongoing treatment.I am not pregnant, breastfeeding, or able to become pregnant.I am fully active or have some restrictions but can still care for myself.I agree to use birth control if I can have children and am sexually active.
- Group 1: Dose escalation - Arm 1B
- Group 2: Dose expansion - Arm 2A
- Group 3: Dose expansion - Arm 2B
- Group 4: Dose escalation - Arm 1A
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is enrollment for this research endeavor still available?
"This clinical trial is still recruiting participants, as indicated by the information on clinicaltrials.gov. The research was uploaded to the website in October of 2022 with a subsequent update made in November of that year."
Has the FDA granted a license for BAY3375968?
"Limited efficacy and safety data supporting BAY3375968 led to a score of 1 on our team's rating scale. This indicates that it is in the initial phase of clinical trials."
What is the current participant intake for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this trial is actively looking for participants and was initially uploaded on October 11th 2022 before being updated on November 14th of the same year. 270 people are needed from 4 distinct sites in order to reach completion."
In how many regions is this clinical test being conducted?
"This trial is taking place at 4 different sites, including the University of Chicago in Chicago, Princess Margaret Cancer Centre in Toronto, and Ohio State University in Columbus. Additionally, there are other locations that have been selected for this study."
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