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PD-L1 Inhibitor

Bapotulimab + Pembrolizumab for Head and Neck 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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Expansion of Bapotulimab in combination with pembrolizumab in Head and neck squamous cell carcinoma (HNSCC): recurrent or metastatic head and neck squamous cell carcinoma IO-naïve PDL1+/ CPS≥1(PD-L1: Programmed death ligand 1; CPS: Combined positive score)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 58 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug combo to see if it's safe, how it affects the body, and if it's effective.

Who is the study for?
This trial is for adults with head and neck cancer that has returned or spread, expressing a protein called PDL1. Participants must be at least 18 years old, have good heart function, and an ECOG performance status of 0 to 1 (which means they are fully active or restricted in physically strenuous activity but can do light work). They should not have had severe immune side effects from previous immunotherapy, no autoimmune diseases, HIV, hepatitis B/C infections, recent serious infections or myocarditis/myositis history.Check my eligibility
What is being tested?
The study tests a new drug named Bapotulimab in combination with Pembrolizumab on patients with recurrent or metastatic Head and Neck Cancer. It aims to determine the safety of this combo treatment, its effects on the body, find the best dose for Bapotulimab and assess how well it works against tumors.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to both drugs' action on the immune system which could lead to inflammation in various organs. There might also be infusion-related reactions alongside common issues like fatigue and digestive disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can carry out all my daily activities without help.
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My head and neck cancer is spreading, hasn't had immunotherapy, and tests positive for PD-L1.
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I have a tumor that can be measured on a scan and it's advanced or has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 58 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 58 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg
Cmax of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg
Therapeutic procedure
+2 more
Secondary outcome measures
AUC after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Best overall response rate
Cmax,md after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Expansion HNSCC_Combination therapyExperimental Treatment1 Intervention
Patients with head and neck squamous cell carcinoma (HNSCC)
Group II: Dose escalation_MonotherapyExperimental Treatment1 Intervention
Patients with solid tumor types considered immunosensitive
Group III: Dose escalation_Combination therapyExperimental Treatment1 Intervention
Patients with solid tumor types considered immunosensitive

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,858 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,433 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,819 Total Patients Enrolled

Media Library

Bapotulimab (BAY1905254) (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03666273 — Phase 1
Head and Neck Squamous Cell Carcinoma Research Study Groups: Dose escalation_Monotherapy, Dose escalation_Combination therapy, Expansion HNSCC_Combination therapy
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Bapotulimab (BAY1905254) Highlights & Side Effects. Trial Name: NCT03666273 — Phase 1
Bapotulimab (BAY1905254) (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03666273 — Phase 1

Frequently Asked Questions

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

Have any previous investigations looked into the effectiveness of combining Bapotulimab (BAY1905254) and Pembrolizumab?

"Bapotulimab (BAY1905254) + Pembrolizumab was originally explored at City of Hope in 2010, and since then 249 trials have been concluded. Currently, there are 961 active studies taking place throughout Houston, Texas."

Answered by AI

Has the FDA sanctioned the combination of Bapotulimab (BAY1905254) and Pembrolizumab?

"The safety of Bapotulimab (BAY1905254) + Pembrolizumab, being a Phase 1 trial with limited data supporting efficacy and no prior evidence of its safety, was assessed to be a score of 1."

Answered by AI

How many venues are being employed to oversee this clinical research?

"Presently, 11 different medical facilities are running this clinical trial. These sites span Houston, Cleveland and Chicago in addition to 8 other cities. To limit travel expenses for participants, it may be beneficial to opt-in at the nearest clinic."

Answered by AI

Are there any enrollment opportunities for this research endeavor?

"Confirmed. As per clinicaltrials.gov, this medical trial is still recruiting volunteers and was initially announced on September 12th 2018 with its most recent update having taken place November 20th 2022."

Answered by AI

What is the current intake capacity for this medical research?

"Indeed, the evidence on clinicaltrials.gov suggests that this medical research is presently looking for participants. This study was first published on September 12th 2018 and has since been amended as recently as November 20th 2022. Across 11 trial sites, 120 patients must be enrolled in order to complete the study's enrollment criteria."

Answered by AI

For what medical purposes is the combination of Bapotulimab (BAY1905254) + Pembrolizumab frequently utilized?

"Bapotulimab (BAY1905254) + Pembrolizumab is a frequent choice of medication for malignant neoplasms, unresectable melanoma, microsatellite instability high and diseases that have progressed following chemotherapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.
2018. "Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03666273.
~18 spots leftby Apr 2025
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