Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
558 (estimated)
Sponsor
BioNTech SE · Industry
Who this trial is looking for
This trial is looking for patients with specific types of breast cancer who cannot use certain immune therapies. Participants will receive either the study drug or a placebo along with chemotherapy.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with triple-negative breast cancer.
I have a measurable tumor.
I have provided a tissue sample for testing.
I have an ECOG performance status of 0 or 1.
You may not be able to join if
I have had previous treatment for advanced cancer.
I have received certain immunotherapy treatments before.
I took high-dose steroids recently.
I have been vaccinated with live vaccines in the last month.
I received antibiotics within the last two weeks.
I am pregnant, breastfeeding, or planning to become pregnant.
I had major surgery or significant trauma in the last 28 days.
I have undergone an organ transplant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 chemotherap…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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…
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.
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