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CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03454451
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

Brief Summary:
This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Renal Cell Cancer Colorectal Cancer Triple Negative Breast Cancer Cervical Cancer Ovarian Cancer Pancreatic Cancer Endometrial Cancer Sarcoma Squamous Cell Carcinoma of the Head and Neck Bladder Cancer Metastatic Castration Resistant Prostate Cancer Non-hodgkin Lymphoma Drug: CPI-006 Drug: CPI-006 + ciforadenant Drug: CPI-006 + pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1/1b MULTICENTER STUDY TO EVALUATE THE HUMANIZED ANTI-CD73 ANTIBODY, CPI-006, AS A SINGLE AGENT OR IN COMBINATION WITH CIFORADENANT, WITH PEMBROLIZUMAB, AND WITH CIFORADENANT PLUS PEMBROLIZUMAB IN ADULT SUBJECTS WITH ADVANCED CANCERS
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Cohort 1a
CPI-006
Drug: CPI-006
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.

Experimental: Cohort1b
CPI-006 + ciforadenant
Drug: CPI-006 + ciforadenant
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.

Experimental: Cohort 1c
CPI-006 + pembrolizumab
Drug: CPI-006 + pembrolizumab
Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.

Experimental: Cohort 2a
CPI-006
Drug: CPI-006
Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.

Experimental: Cohort 2b
CPI-006 + ciforadenant
Drug: CPI-006 + ciforadenant
Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression.

Experimental: Cohort 2c
CPI-006 + pembrolizumab
Drug: CPI-006 + pembrolizumab
Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
  2. Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
  3. Identify the MDL(maximum dose level) of single agent CPI-006 [ Time Frame: From start of treatment to end of treatment, up to 36 months ]

Secondary Outcome Measures :
  1. Area under the curve (AUC) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
  2. Maximum serum concentration (Cmax) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
  3. Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  2. Documented incurable cancer with one of the following histologies: nonsmall cell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer.
  3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  4. For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease. For Expansion: Subject must have progressed on, be refractory to, or intolerant to 1-3 prior systemic therapies.
  5. Willingness to provide tumor biopsies.

Exclusion Criteria

  1. History of severe hypersensitivity reaction to monoclonal antibodies.
  2. Subjects who have received prior therapy with regimens containing cytotoxicT-lymphocyte antigen-4 (CTLA-4), programmed cell death ligand 1 (PDL1), or PD1 antagonists are NOT permitted to enroll unless all adverse events (AEs) while receiving prior immunotherapy have resolved to Grade 1 or baseline prior to screening.
  3. History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
  4. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
  5. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454451


Locations
Show Show 28 study locations
Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Investigators
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Study Chair: S Mahabhashyam, MD Corvus Pharmaceuticals
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Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03454451    
Other Study ID Numbers: CPI-006-001
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corvus Pharmaceuticals, Inc.:
NSCLC
RCC
TNBC
mCRPC
CRC
Lung Cancer
Kidney Cancer
Rectal Cancer
Breast Cancer
Sarcoma
Endometrial
Pancreatic
Ovarian
SCCHN
NHL
Additional relevant MeSH terms:
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Sarcoma
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Urogenital Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Genital Neoplasms, Female
Uterine Neoplasms
Uterine Diseases
Urologic Neoplasms
Urologic Diseases
Adenocarcinoma
Kidney Neoplasms
Kidney Diseases
Head and Neck Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents