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Study of ARRY-614 Plus Either Nivolumab or Nivolumab+Ipilimumab | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

A Phase Ib/II Study of ARRY-614 Plus Either Nivolumab or Nivolumab+Ipilimumab in Advanced Solid Tumors

NCT04074967•Dan Zandberg

Summary

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.

Detailed Description

This phase Ib/II study of PO administered ARRY-614 in combination with checkpoint immunotherapy. In phase Ib, this includes ARRY-614 plus nivolumab or ARRY-614 + nivolumab+ipilimumab in patients with selected advanced solid tumors. In phase II, this includes ARRY-614 in combination with nivolumab in a combined cohort of NSCLC and HNSCCC as well as two arms with patients having either melanoma and RCC, where ARRY-614 will be combined with nivolumab+ipilimumab. The objective of the Ib phase is to determine the safety, tolerability and recommended phase II dose of ARRY-614 with either nivolumab or nivolumab+ipilimumab combination therapy. The objective of Phase II is to determine best ORR in the three separate phase II arms: ARRY-614 plus nivolumab+ipilimumab in melanoma or RCC as well as ARRY-614 plus nivolumab in a combined cohort of NSCLC and HNSCC. The recommended phase II dose will be informed by the phase Ib safety study of ARRY-614, the plasma PK of ARRY-614 and the metabolite, AR00451575, and the PD effects of ARRY-614 in pre and post dose peripheral blood samples. In phase Ib, trial participants will take ARRY-614 continuously in 3- or 4-week cycles (± 3 days). Nivolumab and nivolumab+ipilimumab therapy will be dosed according to FDA-approved or compendium supported dosing schedule. In phase II, a similar dosing schedule will be pursued once the recommended phase II dose of ARRY-614 has been determined with nivolumab or nivolumab +ipilimumab. ARRY-614 will be given on a daily PO schedule in 3- or 4-week cycles (± 3 days).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years.
•For Phase Ib: Trial participants must have a histologically confirmed malignancy that is metastatic or unresectable for which curative measures do not exist or are no longer effective.
•a.Trial participants must have nivolumab or ipilimumab therapy available and must be appropriate for this therapy.
•For Phase II:
•1. Participants with melanoma who previously experienced disease progression on anti-PD1 (with or without ipilimumab).
•2. Participants with RCC who previously experienced disease progression on anti-PD1 (with or without ipilimumab).
•3. Participants with NSCLC or HNSCC who previously experienced disease progression on anti-PD1 (with or without ipilimumab).
•4. Progression on prior anti-PD1/L1 or anti-PD1/anti-CTLA4 antibodies must meet definitions for primary or secondary resistance and regrowth after stopping therapy as below or there must be documentation by the treating investigator of rapid disease progression such that these criteria cannot be assessed (suggestions from the Society for ImmunoTherapy of Cancer PD1 Resistance Working Group).
•Have an ECOG PS score of 0 or 1 (Appendix 13.A).
•Have an expected survival of ≥3 months.
+31 more criteria

Exclusion Criteria

•Received systemic anticancer therapy or an investigational agent \<2 weeks prior to Day 1 (washout from prior immune based anticancer therapy is 4 weeks). In addition, the first dose of study treatment should not occur before a period ≥5 half-lives of the investigational agent has elapsed (excluding nivolumab therapy or combination anti-PD1/ipilimumab combination therapy in RCC - prior ipilimumab not permitted in melanoma cohort).
•For ST, have underwent hepatic radiation, chemoembolization, and radiofrequency ablation \<4 weeks prior to Day 1.
•Participants must not have had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 (with exception of anti-PD1/ipilimumab combination therapy) or have not recovered (i.e. \< Grade 1 at baseline) from adverse events due to agents administered more than 4 weeks earlier.

Locations (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

June 11, 2020

Primary Completion Date

December 27, 2024

Completion Date

December 31, 2025

Last Updated

November 6, 2025

Enrollment

ACTUAL participants

Conditions

Renal Cell CarcinomaMelanomaSolid TumorNon-small Cell Lung CancerHead and Neck Squamous Cell Carcinoma

Interventions

Phase Ib ARRY-614 + nivolumab

DRUG

Phase Ib ARRY-614 + nivolumab+ipilimumab

DRUG

Phase II ARRY-614 + nivolumab

DRUG

Phase II ARRY-614 + nivolumab+ipilimumab (melanoma)

DRUG

Phase II ARRY-614 + nivolumab+ipilimumab (RCC)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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