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 Opdivo is planned in gynecologic cancers. Clovis also intends to initiate a study of lucitanib in combination with rucaparib in ovarian cancer as an arm of the SEASTAR study,  based on encouraging data of VEGF and PARP inhibitors in combination.  Each of these Phase 1b/2 studies is expected to initiate in mid-2019.

KEY: C Combo, ★ SEASTAR Study Arm

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 (anti-PD1), rucaparib, nivolumab and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy

  • Status

    Enrolling

  • Study Identifier

    NCT03522246

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

with Nivolumab in Ovarian Cancer

  • Trial Name

    ARIES: A phase 2, open-label study to evaluate rucaparib in combination with nivolumab in patients with relapsed ovarian cancer.

  • Overview

    A Phase 2, open-label, multi-cohort study evaluating combination of rucaparib and nivolumab as treatment for patients with relapsed ovarian cancer (BRCA wild-type/LOHhigh ).  An exploratory cohort will also evaluate the combination in patients with ovarian cancer (BRCA-positive). This study is expect to begin enrolling patients in mid-2019.

  • Status

    Planned

  • Study Identifier

    TBD

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

Multiple Tumor Types with a Mutation in Certain Genes

  • Trial Name

    Rucaparib Pan-Tumor Study in Multiple Tumor Types with a Mutation in Certain Genes

  • Overview

    Pan-tumor study in patients with multiple tumor types with a mutation in certain genes likely to confer sensitivity to Rubraca, which is expected to begin by year-end 2019.

  • Status

    Planned

  • Study Identifier

    TBD

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

Multiple Tumor Types

  • Trial Name

    Rucaparib with Sacituzumab Govitecan

  • Overview

    Rucaparib and sacituzumab govitecan, an antibody drug conjugate, for the treatment of advanced metastatic triple-negative breast cancer, relapsed platinum-resistant ovarian cancer and potentially advanced metastatic urothelial cancers, is expected to begin enrolling patients in 2019.

  • Status

    Planned

  • Study Identifier

    TBD

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 RUCA-J study, sponsored by Clovis, initiated during the quarter with the first patient dosed with rucaparib in Japan. 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

    Lucitanib with Rucaparib

  • Overview

    Phase 1b/2 combination study is expected to initiate mid-2019.

  • Status

    Planned

  • Study Identifier

    TBD

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

Gynecologic Cancers and Other Tumor Types

  • Trial Name

    Lucitanib with Nivolumaab

  • Overview

    Phase 1b/2 study expected to initiate mid-2019.

  • Status

    Planned

  • Study Identifier

    TBD

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 and prostate cancers are underway, 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 Rucaparib<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 Investigation immunotherapy study of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in metastatic castration-resistance prostate cancer. The nivolumab + rucaparib combination in metastatic castration-resistant prostate cancer (mCRPC) will be 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