Pembrolizumab in Combination With Ibrutinib for Advanced, Refractory Colorectal 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: NCT03332498|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Colorectal Cancer Colorectal Carcinoma Colon Disease||Drug: Pembrolizumab Drug: Ibrutinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Pembrolizumab in Combination With Ibrutinib for Advanced, Refractory Colorectal Cancers|
|Actual Study Start Date :||January 18, 2018|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2022|
Experimental: Pembrolizumab and Ibrutinib
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W).
Ibrutinib by mouth (PO): Phase I Dose Escalation at doses of 420 mg daily (cohort 0) and 560 mg daily (cohort 1);. Phase II treatment at Recommended Phase II dose.
200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
Other Name: Keytruda®
Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
Other Name: Imbruvica®
- Phase I - Recommended Phase II Dose (RP2D) [ Time Frame: 42 days post first dose ]Standard 3+3 Design: The first cohort will enroll a minimum of 3 participants, according to a standard 3+3 design. If 0 out of the first 3 participants in the first cohort experience a dose-limiting toxicity (DLT), then dose escalation will continue as planned. If 1 out of the first 3 participants experience a DLT, then the cohort will be expanded to a total of 6 participants, and if no more than 1 out of 6 participants experiences a DLT in a given dose cohort, dose escalation will continue as planned. If ≥ 2 DLTs are observed in the first dose cohort, the principle investigator will discuss with Janssen on how to proceed. The DLT evaluation period will be defined as the time from the first dose of pembrolizumab and ibrutinib to 42 days after the first dose or if a participant experiences a DLT within this time period. A maximum of 2 cohorts is expected, making a total of approximately 12 evaluable participants during the dose escalation phase.
- Phase II - Disease Control Rate at 4 Months [ Time Frame: 4 months ]Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST based immune-related response criteria (irRC).
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): NCT03332498
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Maria Martinez Jimenez 813-745-1946 email@example.com|
|Contact: Richard Kim, M.D. 813-745-1277 firstname.lastname@example.org|
|Principal Investigator: Richard Kim, M.D.|
|Principal Investigator:||Richard Kim, M.D.||H. Lee Moffitt Cancer Center and Research Institute|