Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)
Completed · Phase 2
Conditions studied: Triple Negative Breast Neoplasms
In brief
The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: 1. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). 2. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.
Key facts
- Study ID
- NCT04191135
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 462
- Starts
- 2019-12-19
- Expected to finish
- 2025-11-26
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Induction Period:
- Has locally recurrent inoperable TNBC that has not previously been treated with chemotherapy and that cannot be treated with curative intent OR has metastatic TNBC that has not been previously treated with chemotherapy
- Has been treated with anthracycline and/or a taxane in the neoadjuvant/adjuvant setting, if they received systemic treatment in the neoadjuvant/adjuvant setting, unless anthracycline and/or taxane was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician
- Has measurable disease based on RECIST 1.1
- Has provided a recently obtained or archival (no more than 3 years old) core or excisional biopsy of a tumor lesion not previously irradiated
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 7 days prior to the start of induction study treatment
- Has a life expectancy ≥27 weeks from the day of first study treatment
- Demonstrate adequate organ function within 10 days prior to the start of study treatment
- A male participant must agree to be abstinent or use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention (95 days for olaparib and chemotherapy; no requirement for pembrolizumab)
- A female participant must not be pregnant or breastfeeding and must agree to the following if is a woman of childbearing potential (WOCBP): have a negative pregnancy test within 24 hours before the start of study treatment and agree to be abstinent or use contraception and refrain from donating eggs (ova, oocytes) during the intervention period and for at least the time needed to eliminate each study intervention (180 days for olaparib and chemotherapy; 120 days for pembrolizumab)
- Post-induction Period:
- Has received up to 6 cycles but not less than 4 cycles of induction therapy without permanently discontinuing from pembrolizumab or both carboplatin and gemcitabine
- Has achieved complete response (CR), partial response (PR), or stable disease (SD) based on RECIST 1.1 by Blinded Independent Central Review (BICR) at the Week 18 evaluation
- Is able to complete during post-induction at least the Cycle 1, Day 1 doses of olaparib and pembrolizumab or the Cycle 1, Day 1 doses of at least one of the chemotherapy agents being administered at the end of induction (carboplatin and/or gemcitabine) in addition to pembrolizumab
- Has ECOG performance status of 0 or 1, as assessed within 7 days prior to the start of post-induction study treatment
- Has no higher than Grade 1 toxicities related to induction therapy (excluding alopecia) prior to randomization
You may not qualify if…
- Induction Period:
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
- Has a history of (non-infectious) pneumonitis\\interstitial lung disease that required steroids or current pneumonitis\\interstitial lung disease
- Has active, or a history of, interstitial lung disease
- Has a known history of active tuberculosis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months of first study treatment
- Has neuropathy ≥Grade 2
- Has not recovered (eg, to ≤Grade 1 or to baseline) from AEs due to a previously administered therapy
- Has a known history of hypersensitivity or allergy to pembrolizumab, olaparib and any of its components, and/or to any of the study chemotherapies (eg, carboplatin or gemcitabine) and any of their components
- Has severe hypersensitivity (≥Grade 3) to the study treatments and/or any of their excipients
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 180 days after the last dose of study treatment
- Is a WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation
- Has received prior therapy with either olaparib or any other poly adenosine diphosphate ribose polymerase (PARP) inhibitor
- Has received prior radiotherapy within 2 weeks of start of study treatment
- Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment
- Has had an allogenic tissue/solid organ transplant.
- Has received previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT)
Where it is running
- CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011) — Laval, Quebec, Canada
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003) — Montreal, Quebec, Canada
- Jewish General Hospital ( Site 0010) — Montreal, Quebec, Canada
- McGill University Health Centre ( Site 0002) — Montreal, Quebec, Canada
- Centro Investigación del Cáncer James Lind ( Site 0510) — Temuco, Araucania, Chile
- IC La Serena Research ( Site 0511) — La Serena, Coquimbo Region, Chile
- Fundacion Arturo Lopez Perez ( Site 0500) — Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile ( Site 0501) — Santiago, Region M. de Santiago, Chile
- Oncocentro ( Site 0502) — Viña del Mar, Valparaiso, Chile
- Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601) — Medellín, Antioquia, Colombia
- Clinica de la Costa Ltda. ( Site 0600) — Barranquilla, Atlántico, Colombia
- Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609) — Barranquilla, Atlántico, Colombia
- Oncomedica S.A. ( Site 0606) — Montería, Departamento de Córdoba, Colombia
- Fundacion Valle del Lili ( Site 0602) — Cali, Valle del Cauca Department, Colombia
- Hemato Oncologos S.A. ( Site 0603) — Cali, Valle del Cauca Department, Colombia
- Centre Francois Baclesse ( Site 1012) — Caen, Calvados, France
- CHU-Jean Minjoz ( Site 1013) — Besançon, Doubs, France
- Institut Claudius Regaud IUCT Oncopole ( Site 1001) — Toulouse, Haute-Garonne, France
- Centre de Cancerologie du Grand Montpellier ( Site 1009) — Montpellier, Languedoc-Roussillon, France
- CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007) — Metz, Moselle, France
- Centre Jean Perrin ( Site 1003) — Clermont-Ferrand, Puy-de-Dome, France
- Centre Leon Berard ( Site 1018) — Lyon, Rhone, France
- Centre Henri Becquerel ( Site 1020) — Rouen, Seine-Maritime, France
- CHU Amiens Hopital Sud ( Site 1023) — Amiens, Somme, France
- Princess Margaret Cancer Centre ( Site 0005) — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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