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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 of care. - Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. - Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial). - Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria

  • Have received any of the following therapies or drugs prior to the initiation of trial: - Have received prior systemic anticancer therapy for advanced disease. - Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody. - Have received systemic corticosteroids (at a dosage greater than 10 milligrams [mg]/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (<= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens). - Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment. - Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment. - Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo. - Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed. - Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy 		Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen.
  • Drug: Pumitamig
    Solution for intravenous (IV) infusion
    Other names:
    • BNT327
    • PM8002
    • BMS-986545
  • Drug: Nab-paclitaxel/Paclitaxel
    IV infusion
  • Drug: Gemcitabine
    IV infusion
  • Drug: Carboplatin
    IV infusion
  • Drug: Eribulin
    IV infusion
Placebo Comparator
Arm 2: Placebo + TPC Chemotherapy 		Participants will be administered with matching placebo plus chemotherapy regimen.
  • Drug: Nab-paclitaxel/Paclitaxel
    IV infusion
  • Drug: Gemcitabine
    IV infusion
  • Drug: Carboplatin
    IV infusion
  • Drug: Eribulin
    IV infusion
  • Drug: Matching placebo
    IV infusion

Recruiting Locations

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

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Livingston, New Jersey 07039

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Long Branch, New Jersey 07740

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
New Brunswick, New Jersey 08901

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Newark, New Jersey 07112

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Somerville, New Jersey 08876

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Toms River, New Jersey 08755

Paradigm New York Cancer and Blood Specialists
Bay Shore, New York 11706

Paradigm New York Cancer and Blood Specialists
New York, New York 10028

Paradigm New York Cancer and Blood Specialists
New York, New York 10469

Paradigm New York Cancer and Blood Specialists
New York, New York 11042

Paradigm New York Cancer and Blood Specialists
New York, New York 11210

Paradigm New York Cancer and Blood Specialists
New York, New York 11702

Paradigm New York Cancer and Blood Specialists
New York, New York 11772

Paradigm New York Cancer and Blood Specialists
New York, New York 11776

Paradigm New York Cancer and Blood Specialists
New York, New York 11901

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

Oncology Specialists of Charlotte Pa
Charlotte, North Carolina 28204

Carolina Oncology Specialists
Charlotte, North Carolina 28210

St Charles Bend Cancer Center
Bend, Oregon 97701

St. Charles Cancer Center - Redmond
Redmond, Oregon 97756

Oregon Oncology Specialists
Salem, Oregon 97301

The West Clinic, P.C. dba West Cancer Center
Germantown, Tennessee 38002

OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
Arlington, Texas 76104

OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
Burleson, Texas 76028

UT Southwestern Medical Center at Redbird
Dallas, Texas 75237

University Of Texas Southwestern Medical Center
Dallas, Texas 75390

JPS Health Network - Trinity Springs Pavilion
Fort Worth, Texas 76104

OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
Fort Worth, Texas 76104

UT Southwestern Moncrief Cancer Institute
Fort Worth, Texas 76104

Oncology Consultants PA
Houston, Texas 77024

Oncology Consultants PA
Houston, Texas 77030

UT Southwestern Medical Center at Richardson/Plano
Richardson, Texas 75080

OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
Weatherford, Texas 76068

Bon Secours Cancer Institute at Memorial Regional
Mechanicsville, Virginia 23116

Bon Secours St. Francis Medical Center
Midlothian, Virginia 23114

Bon Secours Cancer Institute at St. Mary's
Richmond, Virginia 23226

Northwest Medical Specialties, PLLC
Tacoma, Washington 98405

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
BioNTech SE

Study Contact

BioNTech clinical trials patient information
+49 6131 9084
patients@biontech.de

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.