Product Candidates

Rucaparib

Rucaparib, an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents.  Exploratory studies in other tumor types are also underway. Clovis holds global rights for rucaparib.

Lucitanib

Lucitanib, an investigational angiogenesis inhibitor, including vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis has global rights (excluding China) for lucitanib.

FAP-2286 and Peptide-Targeted Radiotherapy Development Program

The Company’s peptide-targeted radiopharmaceutical therapy development program includes lead compound FAP-2286 and three additional unnamed preclinical targets discovered by 3B Pharmaceuticals. The initial focus is on developing FAP-2286 a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.1 Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

 

1 Rettig, 1993, Cancer Research

Clovis-Sponsored Studies

ARIEL4

Ovarian Cancer

  • Trial Name

    ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

  • Overview

    Confirmatory Phase 3 multicenter, randomized study of rucaparib versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy. The primary endpoint of the study is PFS. 

  • Status

    Enrolling

  • Study Identifier

    NCT02855944

ATHENA

with Nivolumab in Ovarian Cancer

  • Trial Name

    ATHENA (A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

  • Overview

    Phase 3 study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating rucaparib plus nivolumab (PD-1 inhibitor), rucaparib, nivolumab and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy. The primary endpoint of this study is PFS. This study is part of a broad clinical collaboration with Bristol Myers Squibb. 

  • Status

    Target Enrollment Complete

  • Study Identifier

    NCT03522246

TRITON3

Prostate Cancer

  • Trial Name

    TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency

  • Overview

    Randomized open-label Phase 3 study evaluating the effects of rucaparib compared to physician’s choice of therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) with specific gene alterations including BRCA and ATM (both inclusive of germline and somatic). Not all patients will receive rucaparib. As part of this study, genetic testing results will be provided. Eligible patients must have progressed on one prior androgen-receptor targeted therapy and must not have received prior chemotherapy for castration-resistant prostate cancer. The primary endpoint of the study is progression-free survival. For more information, please visit www.tritontrials.com.

  • Status

    Enrolling

  • Study Identifier

    NCT02975934

LODESTAR

Solid Tumors with Mutations in HRR Genes

  • Trial Name

    Rucaparib in Patients with Solid Tumors and with Deleterious Mutations in Homologous Recombination Repair (HRR) Genes (LODESTAR)

  • Overview

    A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in patients with various solid tumors and with deleterious mutations in homologous recombination repair (HRR) genes.

  • Status

    Enrolling

  • Study Identifier

    NCT04171700

SEASTAR-B

with Sacituzumab Govitecan in Multiple Tumor Types

  • Trial Name

    SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor

  • Overview

    A Phase 1b/2 study of rucaparib and sacituzumab govitecan, an antibody drug conjugate, for the treatment of advanced metastatic triple-negative breast cancer, relapsed platinum-resistant ovarian cancer and advanced metastatic urothelial cancers.

  • Status

    Enrolling

  • Study Identifier

    NCT03992131

LIO-1

with Nivolumab in Gynecologic Cancers

  • Trial Name

    A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

  • Overview

    Phase 1b/2, open-label study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2). This study is part of a broad clinical collaboration with Bristol Myers Squibb.

     

     

  • Status

    Enrolling

  • Study Identifier

    NCT04042116

SEASTAR-A

with Rucaparib in Ovarian Cancer

  • Trial Name

    SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor

  • Overview

    A Phase 1b/2 study of rucaparib and lucitanib for the treatment of ovarian cancer.

  • Status

    Enrolling

  • Study Identifier

    NCT03992131

FAP-2286 (Targeted Radionuclide Therapy)

Solid Tumors

  • Trial Name

    TBD

  • Overview

    TBD

  • Status

    Planned

  • Study Identifier

PARTNER AND RESEARCH INSTITUTION-SPONSORED STUDIES

CASPAR

with Enzalutamide in Prostate Cancer

  • Trial Name

    A Phase 3 Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy

  • Overview

    This randomized, placebo-controlled phase 3 trial is evaluating the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). This study is sponsored by the Alliance for Clinical Trials in Oncology which is part of the National Cancer Institute.

  • Status

    Planned

  • Study Identifier

    NCT04455750

CheckMate 9KD

with Nivolumab in Prostate Cancer

  • Trial Name

    A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

  • Overview

    A Phase 2 Investigational immunotherapy study of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in metastatic castration-resistance prostate cancer (mCRPC). The nivolumab + rucaparib combination in mCRPC is being conducted as an arm of a larger Bristol Myers Squibb-sponsored study. This study is sponsored by Bristol Myers Squibb.

  • Status

    Enrolling

  • Study Identifier

    NCT03338790

FRACTION-GC

with Nivolumab and Ipilimumab in Gastric Cancer

  • Trial Name

    A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer (FRACTION-GC)

  • Overview

    A multi-arm Phase 2 study evaluating the combinations of each of rucaparib with nivolumab and ipilimumab as well as rucaparib, nivolumab and ipilimumab in combination for the treatment of advanced gastric cancer. This study is sponsored by Bristol Myers Squibb.  

     

  • Status

    Enrolling

  • Study Identifier

    NCT02935634

CheckMate 79X

with Nivolumab in Lung Cancer

  • Trial Name

    Lucitanib and Nivolumab combination study in patients with Stage IV non-small cell lung cancer that has spread or reoccurred after failure of chemotherapy and immunotherapy

  • Overview

    Phase 1/2 combination study sponsored by Bristol Myers Squibb will evaluate multiple combinations with nivolumab, including an arm in combination with lucitanib, in patients with Stage IV non-small cell lung cancer that has spread or reoccurred after failure of chemotherapy and immunotherapy. 

  • Status

    Planned

  • Study Identifier

    TBD