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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03454451




Registration number
NCT03454451
Ethics application status
Date submitted
5/02/2018
Date registered
6/03/2018
Date last updated
21/12/2023

Titles & IDs
Public title
CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
Scientific 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
Secondary ID [1] 0 0
CPI-006-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Renal Cell Cancer 0 0
Colorectal Cancer 0 0
Triple Negative Breast Cancer 0 0
Cervical Cancer 0 0
Ovarian Cancer 0 0
Pancreatic Cancer 0 0
Endometrial Cancer 0 0
Sarcoma 0 0
Squamous Cell Carcinoma of the Head and Neck 0 0
Bladder Cancer 0 0
Metastatic Castration Resistant Prostate Cancer 0 0
Non-hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CPI-006
Treatment: Drugs - CPI-006 + ciforadenant
Treatment: Drugs - CPI-006 + pembrolizumab
Treatment: Drugs - CPI-006
Treatment: Drugs - CPI-006 + ciforadenant
Treatment: Drugs - CPI-006 + pembrolizumab

Experimental: Cohort 1a - CPI-006

Experimental: Cohort1b - CPI-006 + ciforadenant

Experimental: Cohort 1c - CPI-006 + pembrolizumab

Experimental: Cohort 2a - CPI-006

Experimental: Cohort 2b - CPI-006 + ciforadenant

Experimental: Cohort 2c - CPI-006 + pembrolizumab


Treatment: Drugs: CPI-006
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: CPI-006
Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.

Treatment: Drugs: 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.

Treatment: Drugs: CPI-006 + pembrolizumab
Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
Timepoint [1] 0 0
From start of treatment to end of treatment, up to 36 months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
From start of treatment to end of treatment, up to 36 months
Primary outcome [3] 0 0
Identify the MDL(maximum dose level) of single agent CPI-006
Timepoint [3] 0 0
From start of treatment to end of treatment, up to 36 months
Secondary outcome [1] 0 0
Area under the curve (AUC) of CPI-006
Timepoint [1] 0 0
Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Secondary outcome [2] 0 0
Maximum serum concentration (Cmax) of CPI-006
Timepoint [2] 0 0
Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Secondary outcome [3] 0 0
Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
Timepoint [3] 0 0
From start of treatment to end of treatment, up to 36 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/02/2023
Sample size
Target
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Westmead - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane - Herston
Recruitment hospital [5] 0 0
Monash Hospital - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3168 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Corvus Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03454451
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
S Mahabhashyam, MD
Address 0 0
Corvus Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03454451