Bristol-Myers Squibb and Clovis Oncology entered a clinical collaboration to evaluate the combination of nivolumab and rucaparib for treatment of three tumor types.
The collaboration will include two pivotal phase 3 trials and one phase 2 trial designed to assess the PD-1 checkpoint inhibitor nivolumab (Opdivo, Bristol-Myers Squibb) in combination with the PARP inhibitor rucaparib (Rubraca, Clovis Oncology).
“This clinical collaboration addresses areas of unmet medical need where the combination of Opdivo and Rubraca may lead to an additional treatment option for patients with difficult-to-treat cancers,” Fouad Namouni, MD, head of oncology development at Bristol-Myers Squibb, said in a company-issued press release. “We are committed to investigating a wide range of oncology therapies and look forward to studying the combination of Clovis’ PARP inhibitor and our immunotherapy.”
One phase 3 trial will assess three regimens — nivolumab plus rucaparib, rucaparib alone and nivolumab alone — as first-line maintenance treatment for women with stage III/stage IV high-grade ovarian, fallopian tube or primary peritoneal cancers who completed platinum-based chemotherapy.
A second phase 3 trial will evaluate the same three regimens as first-line maintenance treatment for patients with stage IV or recurrent, locally advanced, inoperable triple-negative breast cancers associated with a homologous recombination deficiency.
A phase 2 study will evaluate the efficacy and safety of the combination for patients with metastatic castration-resistant prostate cancer.
“We are very enthusiastic about studying Rubraca and Opdivo in combination and the potential to create new treatment options for patients with multiple tumor types, as well as for patients beyond those with BRCA mutations,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in the release. “This substantial clinical collaboration in ovarian, triple-negative breast and prostate cancers represents a significant effort by Clovis and Bristol-Myers Squibb to realize that potential.”
Under the agreement, Clovis will be the study sponsor and conducting party for the study in ovarian cancer. Bristol-Myers Squibb will be the study sponsor and conducting party for the breast cancer and prostate cancer studies.