Description:
The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.
The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.
Active, not recruiting
Phase 1/Phase 2
NCT ID: NCT02178722
ORG ID: INCB 24360-202
Cancer, Solid Tumor
Drug | Synonyms | Arms |
---|---|---|
INCB024360 | Phase 1: MK-3475 2 mg/kg + INCB024360 25 mg BID, Phase 2: MK-3475 selected dose + INCB024360 | |
MK-3475 | Phase 1: MK-3475 2 mg/kg + INCB024360 25 mg BID, Phase 2: MK-3475 selected dose + Placebo, Phase 2: MK-3475 selected dose + INCB024360 | |
Placebo | Phase 2: MK-3475 selected dose + Placebo |
This study will be conducted in 2 phases. Phase 1 will include subjects with several
different advanced or metastatic solid tumors and will test different doses of INCB024360 in
combination with MK-3475 in order to select a dose for further evaluation. Phase 2 will
include patients with advanced NSCLC only and will be randomized, double-blind and
placebo-controlled utilizing the dose selected in Phase 1 to further evaluate the efficacy
of this combination of MK-3475 and INCB024360.
Name | Type | Description | Interventions |
---|---|---|---|
Phase 1: MK-3475 2 mg/kg + INCB024360 25 mg BID | Experimental | Experimental: MK-3475 2 mg/kg given once every 3 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations (Phase 1) until recommended phase 2 dose of INCB024360 is determined | INCB024360, MK-3475 |
Phase 2: MK-3475 selected dose + Placebo | Experimental | Experimental: MK-3475 selected dose given once every 3 weeks + Placebo | MK-3475, Placebo |
Phase 2: MK-3475 selected dose + INCB024360 | Experimental | MK-3475 selected dose given once every 3 weeks + INCB024360 (recommended phase 2 dose) | INCB024360, MK-3475 |
Inclusion Criteria:
- Subjects with histologically or cytologically NSCLC, melanoma, transitional cell
carcinoma of the GU tract, renal cell cancer, triple negative breast cancer,
adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck
(Phase 1)
- Subjects with histologically or cytologically Stage IIIb, IV, or recurrent NSCLC
(Phase 2)
- Life expectancy > 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
- Presence of measurable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1
- Laboratory and medical history parameters within protocol-defined range.
- For Phase 1: Subjects who have advanced or metastatic disease as noted above that
have received at least one prior therapy or have advanced or metastatic disease for
which no curative treatment is available may be enrolled.
- For Phase 2: Subjects who have received only 1 prior systemic chemotherapy regimen
for Stage IIIb, IV, or recurrent NSCLC (not including neo-adjuvant and/or adjuvant
therapy). Prior systemic therapies must include a platinum-based regimen. Tumors with
driver mutations (EGFR mutation positive or anaplastic lymphoma kinase fusion
oncogene positive) treated with a tyrosine kinase inhibitor are permitted and will
not be considered a second systemic chemotherapy regimen.
- Tumor biopsies are required
- Females of child-bearing potential and males who use adequate birth control through
120 days post dose.
Exclusion Criteria:
- Subjects who participated in any other study in which receipt of an investigational
study drug or device occurred within 28 days or 5 half-lives (whichever is longer)
prior to first dose.
- Subjects who have received more than one prior systemic treatment for Stage IIIb, IV,
or recurrent NSCLC (Phase 2).
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including
ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation
or checkpoint pathways).
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Subjects with previously treated brain metastases may participate
provided they are stable
- Has an active autoimmune disease.
- Has evidence of interstitial lung disease or pneumonitis.
- Live vaccine use within 30 days of first dose of study medication
- Monoamine oxidase inhibitors
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Phase 1: Number of subjects with dose limiting toxicities (DLTs) of INCB024360 in combination with MK-3475
Phase 2: Progression free survival (PFS)
Objective response rate
Number of subjects with Adverse Events as a Measure of Safety and Tolerability of INCB024360 in combination with MK-3475
Overall survival (OS)