A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease
Summary
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
Detailed description
The study consists of a: 1. Screening period (up to 28 days); 2. Treatment period, during which participants will receive pumitamig or placebo in combination with chemotherapy (until disease progression, the occurrence of intolerable toxicity, withdrawal, death, or trial termination \[whichever comes first\]); 3. Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first). Participants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors: * Prior treatment with cancer immunotherapy (yes versus no) * On-trial chemotherapy regimen (paclitaxel/nab-paclitaxel versus gemcitabine plus carboplatin versus eribulin) * Geography (East Asia versus the rest of the world \[ROW\]) * PD-L1 status (combined positive score \[CPS\] less than \[\<\] 1 versus 1 less than or equal to \[\<=\] CPS \<10).
Arms & interventions
- DrugPumitamig
Solution for intravenous (IV) infusion
- DrugNab-paclitaxel/Paclitaxel
IV infusion
- DrugGemcitabine
IV infusion
- DrugCarboplatin
IV infusion
- DrugEribulin
IV infusion
- DrugMatching placebo
IV infusion
Outcome measures
Primary
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per response evaluation criteria in solid tumors \[RECIST\] v1.1), or death from any cause, whichever occurs first.
Time frame: Up to approximately 32 months
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame: Up to approximately 49 months
Secondary
Objective Response Rate (ORR) as Assessed by BICR
Time frame: Up to approximately 49 months
PFS
Time frame: Up to approximately 32 months
ORR
Time frame: Up to approximately 49 months
Duration of Response (DOR)
Time frame: Up to approximately 49 months
Disease Control Rate (DCR)
Time frame: Up to approximately 32 months
PFS Rate as Assessed by BICR
Time frame: At 6, 12, 18, and 24 months
PFS Rate as Assessed by Investigator
Time frame: At 6, 12, 18, and 24 months
OS Rate
Time frame: At 6, 12, 18, and 24 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs) Including Grade Greater than or Equal to (>=) 3, Serious, and Fatal TEAEs by Relationship
Time frame: From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)
Occurrence of Dose Interruption, Reduction, and Discontinuation of Trial Treatment due to TEAEs (including related TEAEs)
Time frame: From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 Questionnaire (QLQ-C30) Global Health Status/Quality-of-Life score (Items 29 and 30)
Time frame: Baseline up to approximately 49 months
Change from Baseline in EORTC QLQ-C30 Physical Functioning
Time frame: Baseline up to approximately 49 months
Change from Baseline in Arm Symptoms Scale of EORTC QLQ-Breast Cancer (BR)42
Time frame: Baseline up to approximately 49 months
Change from Baseline in Breast Symptoms Scale of EORTC QLQ-BR42
Time frame: Baseline up to approximately 49 months
Change from Baseline in Functional Assessment of Cancer Therapy-General Version (FACT-G) Overall Bother Item (FACT-GP5)
Time frame: Baseline up to approximately 49 months
Eligibility criteria
Study locations (26)
Highlands Oncology Group
Springdale, Arkansas, 72762
University Of California - San Diego Moores Cancer Center
La Jolla, California, 92037
Cedar Sinai - Samuel Oschin Cancer Center
Los Angeles, California, 90048
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto, California, 94304-2201
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
Cancer Care Specialists
Decatur, Illinois, 62526
Cancer Care Specialists of Illinois
O'Fallon, Illinois, 62269
Carle Foundation Hospital d/b/a Carle Cancer Center
Urbana, Illinois, 61801
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, Kentucky, 40202
New England Cancer Specialists
Westbrook, Maine, 04092
Saint Agnes Hospital, Clinical Research Center
Baltimore, Maryland, 21229
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Karmanos Cancer Center
Detroit, Michigan, 48201
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, Michigan, 48073
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Oncology Hematology West, PC dba Nebraska Cancer Specialist
Grand Island, Nebraska, 68803
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68310
Summit Medical Group PA
Florham Park, New Jersey, 07932
Rochester General Hospital Lipson Cancer Institute
Rochester, New York, 14621
Stony Brook University Medical Center
Stony Brook, New York, 11794
Montefiore Medical Center
The Bronx, New York, 10461
Oregon Oncology Specialists
Salem, Oregon, 97301
The West Clinic, P.C. dba West Cancer Center
Germantown, Tennessee, 38002
Oncology Consultants PA
Houston, Texas, 77024
Oncology Consultants PA
Houston, Texas, 77030
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405