Product Candidates

Rucaparib

Rucaparib, an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in ovarian cancer as well as several additional solid tumor indications.  Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancers. Clovis holds worldwide rights for rucaparib.

Lucitanib

Lucitanib, an investigational, oral, potent inhibitor of the tyrosine kinase activity of 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). Clovis has global rights (excluding China) for lucitanib.

Recent data for a drug that inhibits these same three pathways - when combined with a PD-1 inhibitor - are extremely encouraging and represent a scientific rationale for the development of lucitanib in combination with a PD-1 inhibitor, and a Clovis-sponsored study of lucitanib in combination with nivolumab is underway in advanced gynecologic cancers and other solid tumors. Based on encouraging data of VEGF and PARP inhibitors in combination, a study of lucitanib in combination with rucaparib in advanced ovarian cancer is also underway as an arm of the SEASTAR study.  Each of these Phase 1b/2 studies is currently enrolling patients, and initial data are anticipated at medical meetings beginning in mid-2020. 

KEY: C Combo, ★ SEASTAR Study Arm

FAP-2286 

In September 2019, Clovis and 3B Pharmaceuticals GmBH (3BP) entered into a global licensing and collaboration agreement with an initial focus 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 (inclusive of Russia, Turkey and Israel), where 3BP retains rights. Clovis currently plans to file an Investigational New drug Application (IND) for FAP-2286 in the second half of 2020.

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<sup><b>C</b></sup>

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

    Enrolling

  • 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

TRITON2

Prostate Cancer

  • Trial Name

    TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

  • Overview

    Single-arm Phase 2 in patients with BRCA mutations (inclusive of germline or somatic) and also enrolling patient with deleterious mutations of other homologous recombination (HR) repair genes. All patients will have progressed on at least one or two lines of androgen-receptor targeted therapy. The primary endpoints of the study are confirmed radiologic overall response rate per modified RECIST/PCWG3 in patients with measurable disease and PSA response rate in patients without measurable disease. For more information, please visit www.tritiontrials.com.

  • Status

    Enrolling

  • Study Identifier

    NCT02952534

Pan-Tumor

Solid Tumors with Mutations in HRR Genes

  • Trial Name

    Rucaparib Pan-Tumor Study in Patients Solid Tumors Associated with Deleterious Mutations in Homologous Recombination Repair (HRR) Genes

  • Overview

    Pan-tumor study in patients with solid tumors associated with deleterious mutation in homologous recombination repair (HRR) genes, which is expected to begin by year-end 2019 or early 2020.

  • Status

    Planned

  • Study Identifier

    TBD

Sacituzumab Govitecan Combo<sup><b>C</b>,&starf;</sup>

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

RUCA-J

Safety and PK study in Japanese patients

  • Trial Name

    A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

  • Overview

    The Phase 1 study seeks to identify the recommended dose of rucaparib in Japanese patients, which will enable development of a bridging strategy and potential inclusion of Japanese sites in planned or ongoing global studies.

  • Status

    Enrolling

  • Study Identifier

    NCT03499444

Rucaparib Combo<sup><b>C</b>,&starf;</sup>

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

Nivolumab Combo<sup><b>C</b></sup>

Gynecologic Cancers and Other Solid Tumors

  • 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 evaluate the safety and efficacy of lucitanib in combination with nivolumab in patients with advanced gynecologic cancers and other solid tumors.  This study is part of a broad clinical collaboration with Bristol-Myers Squibb.

  • Status

    Enrolling

  • Study Identifier

    NCT04042116

FAP-2286 (Targeted Radionuclide Therapy)

Solid Tumors

  • Trial Name

    TBD

  • Overview

    TBD

  • Status

    Planned

  • Study Identifier

PARTNER-SPONSORED STUDIES

Clovis is exploring rucaparib and lucitanib in combination with inhibitors of PD-1.

In July 2017, Bristol-Myers Squibb Company (BMS) and Clovis Oncology, Inc. announced a clinical collaboration agreement to evaluate the combination of BMS' immunotherapy nivolumab and Clovis Oncology’s rucaparib.  Exploratory studies in ovarian, prostate, gastric and lung cancers are underway or planned, as well as active discussions with BMS regarding additional potential combination studies. In February 2019, the clinical collaboration with BMS was expanded to include the combination of lucitanib and nivolumab.

CheckMate 9KD<sup><b>C</b></sup>

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<sup><b>C</b></sup>

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 Phase 2 study of rucaparib with nivolumab and ipilimumab for the treatment of advanced gastric cancer is planned to initiate in early 2020 and will be conducted as an arm of a larger Bristol-Myers Squibb-sponsored study. This study will be sponsored by Bristol-Myers Squibb.  

  • Status

    Planned

  • Study Identifier

    NCT02935634

Nivolumab Combo<sup><b>C</b></sup>

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. This study is planned to start by the end of 2019.

  • Status

    Planned

  • Study Identifier

    TBD