Study of ARRY-614 Plus Either Nivolumab or Nivolumab+Ipilimumab

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Dan Zandberg
Study ID
NCT04074967
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phase Ib ARRY-614 + nivolumab — DRUG
    ARRY-614 continuously in 4-week cycles (± 3 days). Nivolumab will be dosed according to FDA-approved dosing schedule.
  • Phase Ib ARRY-614 + nivolumab+ipilimumab — DRUG
    ARRY-614 continuously in 4-week cycles (± 3 days). Nivolumab will be dosed according to FDA-approved dosing schedule. Ipilimumab therapy will be dosed according to FDA-approved dosing schedule.
  • Phase II ARRY-614 + nivolumab — DRUG
    Recommended Phase II dose of ARRY-614 (to be determined) daily in 4-week cycles (± 3 days). Nivolumab will be dosed according to FDA-approved dosing schedule.
  • Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) — DRUG
    Recommended Phase II dose of ARRY-614 (to be determined) daily in 4-week cycles (± 3 days). Nivolumab will be dosed according to FDA-approved dosing schedule. Ipilimumab therapy will be dosed according to FDA-approved dosing schedule.
  • Phase II ARRY-614 + nivolumab+ipilimumab (RCC) — DRUG
    Recommended Phase II dose of ARRY-614 (to be determined) daily in 4-week cycles (± 3 days). Nivolumab will be dosed according to FDA-approved dosing schedule. Ipilimumab therapy will be dosed according to FDA-approved dosing schedule.

Study Details

In this study, the Phase Ib portion aims to establish safety and tolerability of ARRY-614 with either nivolumab or ipilimumab and to determine a recommended phase II dose of ARRY-614 in combination with either nivolumab or nivolumab+ipilimumab immunotherapy in patients with selected advanced solid tumors. The Phase II portion will estimate the efficacy of ARRY-614 in combination with either nivolumab or ARRY-614 + nivolumab+ipilimumab immunotherapy in patients with with NSCLC, HNSCC, melanoma and RCC and melanoma.

Key Dates

Start date
Jun 11, 2020
Status verified
Nov 2025
Primary completion
Dec 27, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
70 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib ARRY-614 + nivolumab
    Participants with advanced solid tumors will receive ARRY-614 in combination with nivolumab. (histologically confirmed metastatic or unresectable malignancy with lacking curative measures; nivolumab must be available and appropriate for proposed therapy)
  • Experimental: Phase Ib ARRY-614 + nivolumab + ipilimumab
    Participants with advanced solid tumors will received ARRY-614 in combination with nivolumab + ipilimumab. (histologically confirmed metastatic or unresectable malignancy with lacking curative measures; nivolumab and ipilimumab must be available and appropriate for proposed therapy)
  • Experimental: Phase II ARRY-614 + nivolumab
    Participants with of NSCLC and HNSCCC will receive ARRY-614 combined with nivolumab.
  • Experimental: Phase II ARRY-614 + nivolumab + ipilimumab (melanoma)
    Participants with melanoma will receive ARRY-614 combined with nivolumab + ipilimumab.
  • Experimental: Phase II ARRY-614 + nivolumab + ipilimumab (RCC)
    Participants with RCC will receive ARRY-614 combined with nivolumab + ipilimumab.

Primary Outcome Measure

Participants Experiencing a Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days (during first cycle of treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

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By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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