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
BioNTech SE
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status. * Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and/or progesterone receptor \[PgR\]) 1% to 10%, HER2 immunohistochemistry \[IHC\] 0, 1+, or 2+ with fluorescence in situ hybridization \[FISH\] negative for HER2 gene amplification) documented prior to trial screening as part of standard o…
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
Locations (83)
- Highlands Oncology GroupSpringdale, Arkansas
- Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer CenterPalo Alto, California
- Cancer Care SpecialistsDecatur, Illinois
- Cancer Care Specialists of IllinoisO'Fallon, Illinois
- Carle Foundation Hospital d/b/a Carle Cancer CenterUrbana, Illinois
- New England Cancer SpecialistsWestbrook, Maine