ARRY-614 + Immune Checkpoint Inhibitors for Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJason Luke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Jason J. Luke, MD

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with certain advanced cancers (like lung, kidney, melanoma) who can receive nivolumab or ipilimumab therapy. They should have a life expectancy of at least 3 months and be willing to undergo biopsies if needed. Participants must not be pregnant, breastfeeding, or have severe heart issues, active brain metastases requiring steroids, recent major surgery without recovery, significant cardiac disease within the past 6 months, active autoimmune diseases treated in the last 2 years, other primary active cancers needing treatment, known hepatitis B/C infections or hypersensitivity to trial drugs.

Inclusion Criteria

You are expected to live for at least 3 more months.

My tumor can be easily biopsied, and I agree to have two biopsies.

Be able to understand and willing to sign the informed consent form

+12 more

Exclusion Criteria

I have another type of cancer that needs treatment.

I have a condition that affects how my body absorbs medication taken by mouth.

I do not have an active infection needing antibiotics or a fever over 38.5°C in the last week.

+16 more

Participant Groups

The study is testing ARRY-614 combined with either nivolumab alone or plus ipilimumab in two phases: Phase Ib for safety and dosage determination and Phase II for efficacy estimation in patients with NSCLC (non-small cell lung cancer), HNSCC (head and neck squamous cell carcinoma), RCC (renal cell carcinoma), and melanoma.

5Treatment groups

Experimental Treatment

Group I: Phase Ib ARRY-614 + nivolumab + ipilimumabExperimental Treatment1 Intervention

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)

Group II: Phase Ib ARRY-614 + nivolumabExperimental Treatment1 Intervention

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)

Group III: Phase II ARRY-614 + nivolumab + ipilimumab (melanoma)Experimental Treatment1 Intervention

Participants with melanoma will receive ARRY-614 combined with nivolumab + ipilimumab.

Group IV: Phase II ARRY-614 + nivolumab + ipilimumab (RCC)Experimental Treatment1 Intervention

Participants with RCC will receive ARRY-614 combined with nivolumab + ipilimumab.

Group V: Phase II ARRY-614 + nivolumabExperimental Treatment1 Intervention

Participants with of NSCLC and HNSCCC will receive ARRY-614 combined with nivolumab.