Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers
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|ClinicalTrials.gov Identifier: NCT02178722|
Recruitment Status : Active, not recruiting
First Posted : July 1, 2014
Results First Posted : December 19, 2019
Last Update Posted : December 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Microsatellite-instability (MSI) High Colorectal Cancer (CRC) Endometrial Cancer Head and Neck Cancer Hepatocellular Carcinoma (HCC) Gastric Cancer Lung Cancer Lymphoma Renal Cell Carcinoma (RCC) Ovarian Cancer Solid Tumors UC (Urothelial Cancer) Melanoma Bladder Cancer Triple Negative Breast Cancer (TNBC)||Drug: MK-3475 Drug: INCB024360||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||444 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Cancers (ECHO-202/KEYNOTE-037)|
|Actual Study Start Date :||July 17, 2014|
|Actual Primary Completion Date :||November 26, 2018|
|Estimated Study Completion Date :||August 2020|
Experimental: Phase 1: MK-3475 + INCB024360
Phase 1: MK-3475 + INCB024360 25 mg twice a day (BID) as starting dose, followed by dose escalations (Phase 1) until recommended phase 2 dose of INCB024360 is determined
Oral daily dosing
Experimental: Phase 2: MK-3475 + INCB024360
(recommended phase 2 dose)
Oral daily dosing
- Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events [ Time Frame: From study start up to clinical data cut-off date of 26 Nov 2018 (approximately 54 months) ]An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
- Phase 2: Objective Response Rate (ORR) [ Time Frame: Assessed every 9 weeks after the first dose of study treatment for the first 2 assessments (Weeks 9 and 18) then every 12 weeks thereafter until data cut-off date of 26 Nov 2018 (approximately 54 months) ]ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)], per modified Response Evaluation Criteria In Solid Tumors (irRECIST) v1.1 criteria for select solid tumors or modified Lugano Classification for diffuse large B-cell lymphoma (DLBCL).
- Phase 2: Duration of Response (DOR) [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks ]Duration of response is the time from the first overall response contributing to an objective response (complete response or partial response) to the date of death or the date of first overall response of progressive disease (whichever is earliest).
- Phase 2: Progression Free Survival (PFS) [ Time Frame: Response is measured every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks ]Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification (Cheson et al 2014) for DLBCL.
- Phase 2: Duration of Disease Control [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks ]The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification Cheson et al 2014), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or bette
- Phase 2: Ordinal Categorical Response Score [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks ]
Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups:
- = Complete response per irRECIST v1.1
- = Very good response, defined as > 60% tumor reduction
- = Minor response, defined as > 30% to ≤ 60% tumor reduction
- = Stable disease per irRECIST v1.1
- = Progressive disease per irRECIST v1.1
- Phase 2: Overall Survival (OS) [ Time Frame: Patients are checked for survival every 12 weeks for duration of study participation which is estimated to be a minimum of 18 weeks ]Overall survival is determined from the date of first dose until death due to any cause.
- Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events [ Time Frame: Adverse events are assessed every 3 weeks for duration of study participation which is estimated to be 27 months ]
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): NCT02178722
|Study Director:||Mark Jones, MD||Incyte Corporation|