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ARRY-614 + Immune Checkpoint Inhibitors for Cancer

Phase 1 & 2

Waitlist Available

Led By Jason J Luke, MD, PhD

Research Sponsored by Jason J. Luke, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Have adequate bone marrow function

Must not have

Have a history of another primary cancer that is active requiring treatment

Have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered PO

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, ARRY-614, to see if it is safe and effective when used with either nivolumab or ipilimumab to treat advanced solid tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs like the liver or lungs; infusion reactions; fatigue; digestive problems such as diarrhea; skin issues like rash; hormonal gland problems leading to hormone imbalances; potential worsening of underlying autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My bone marrow is working well.

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I can receive nivolumab or ipilimumab therapy, and it's suitable for my condition.

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My cancer is advanced, cannot be surgically removed, and cannot be cured with existing treatments.

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My kidneys are functioning well enough (creatinine clearance > 30 mL/min).

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My melanoma/RCC/NSCLC/HNSCC progressed despite anti-PD1 treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am a woman who can have children and have a negative pregnancy test before starting treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another type of cancer that needs treatment.

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

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

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I have an active hepatitis B or C infection.

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I need steroids for my brain cancer symptoms.

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I am currently institutionalized by court or administrative order.

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I have never needed steroids for non-infectious lung inflammation.

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I had major surgery less than 4 weeks ago or am still recovering from surgery side effects.

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I haven't had cancer treatment or experimental drugs in the last 2 weeks.

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I am allergic to ARRY-614 or anti-PD1/ipilimumab treatments.

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I do not have any health or mental conditions that could make this study unsafe for me.

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I haven't needed treatment for an autoimmune disease in the last 2 years.

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I had liver treatments like radiation or ablation less than 4 weeks ago.

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I am not immunodeficient and do not take more than 10 mg of prednisone or its equivalent daily.

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I do not have an active lung condition involving scarring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response

Participants Experiencing a Dose Limiting Toxicity (DLT)

Secondary study objectives

Adverse Events related to Study Treatment

Duration of Response

Overall Survival (OS)

+2 more

Other study objectives

Pharmacodynamic profile of ARRY-614

Pharmacokinetic profile of ARRY-614

Tumor Inflammation Signature (TIS) score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 23Eligibility criteria met