BCA101X301-BCA101/placebo with pembro, 1st line PDL-1 + recurrent or metastatic Head and Neck ca

BCA101X301-BCA101/placebo with pembro, 1st line PDL-1 + recurrent or metastatic Head and Neck ca

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Purpose of this Study

We are doing this study to find the most effective, safe dose of an experimental drug called ficerafusp alfa (BCA101 - the study drug) when it is given in combination with pembrolizumab for people who have metastatic/recurrent head and neck squamous cell carcinoma (HNSCC).

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with HNSCC that has spread (metastatic) and/or returned (recurrent)
  • Have not gotten any previous treatment specifically for metastatic or recurrent disease
  • Have a primary tumor located in one of the following regions: oropharynx, oral cavity, hypopharynx, or larynx
For more information, contact the study team at alicia.wilkerson@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

The study consists of 2 different parts, Phase 2 and Phase 3. If you choose to join this study, whichever part you participate in will depend on when you join the study. Phase 2 This part of the study will compare 2 different doses of the study drug (750 mg once weekly or 1500 mg once weekly) to find out how well both doses work in combination with pembrolizumab. If you participate in Phase 2, you will get an assignment (random chance decided by a computer application) to 1 of 3 study groups called "arms".
  • Arm A: Participants in this arm will take a 1500 mg dose of the study drug once a week + a 200 mg dose of pembrolizumab once every 3 weeks.
  • Arm B: Participants in this arm will take a 750 mg dose of the study drug once a week + a 200 mg dose of pembrolizumab once every 3 weeks.
  • Arm C: Participants in this arm will take a placebo (inactive substance with no drug) once a week + a 200 mg dose of pembrolizumab once every 3 weeks.
Phase 3 This part of the study will only use the dose of the study drug from Phase 2 that seemed to work the best. If you participate in Phase 3, you will get an assignment (random chance decided by a computer application) to 1 of 3 arms.
  • Arm A: Participants in this arm will take the best dose of the study drug from Phase 2 once a week + a 200 mg dose of pembrolizumab once every 3 weeks.
  • Arm B: Participants in this arm will take the best dose of the study drug from Phase 2 once a week + a 200 mg dose of pembrolizumab once every 3 weeks.
  • Arm C: Participants in this arm will take a placebo (inactive substance with no drug) once a week + a 200 mg dose of pembrolizumab once every 3 weeks.
No matter your study assignment, the following procedures will happen during your study visits: physical exams, vital signs, electrocardiograms, tumor imaging (CT/MRI), surveys, blood draws, and tumor biopsies. You will take pembrolizumab for up to 2 years in this study if you are tolerating it well and the study doctor believes that it is benefitting you. You will take the study drug or placebo for up to 5 years in this study if you are tolerating it well and the study doctor believes that it is benefitting you.

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Principal Investigator

Jameel
Muzaffar

Protocol Number

PRO00116842

Phase

II/III

Enrollment Status

Pending Open to Enrollment