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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response
Participants Experiencing a Dose Limiting Toxicity (DLT)
Secondary outcome measures
Adverse Events related to Study Treatment
Duration of Response
Overall Survival (OS)
+2 more
Other outcome measures
Pharmacodynamic profile of ARRY-614
Pharmacokinetic profile of ARRY-614
Tumor Inflammation Signature (TIS) score

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.

Find a Location

Who is running the clinical trial?

Jason J. Luke, MDLead Sponsor
4 Previous Clinical Trials
646 Total Patients Enrolled
3 Trials studying Melanoma
630 Patients Enrolled for Melanoma
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,327 Total Patients Enrolled
5 Trials studying Melanoma
103 Patients Enrolled for Melanoma
Jason J Luke, MD, PhDPrincipal InvestigatorUPMC Hillman Cancer Center
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

ARRY-614 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04074967 — Phase 1 & 2
Melanoma Research Study Groups: Phase II ARRY-614 + nivolumab, Phase Ib ARRY-614 + nivolumab, Phase Ib ARRY-614 + nivolumab + ipilimumab, Phase II ARRY-614 + nivolumab + ipilimumab (melanoma), Phase II ARRY-614 + nivolumab + ipilimumab (RCC)
Melanoma Clinical Trial 2023: ARRY-614 Highlights & Side Effects. Trial Name: NCT04074967 — Phase 1 & 2
ARRY-614 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04074967 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prior examinations of the effects of a combination therapy of Phase II ARRY-614, nivolumab and ipilimumab for melanoma?

"Presently, there are 765 clinical trials for Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) in progress with 86 of these at the final stage. Although a few of them take place in Pittsburgh, PA, 42707 other sites host studies about this medication."

Answered by AI

Are volunteers being enrolled for this clinical research currently?

"As per the clinicaltrials.gov registry, this medical trial is currently in need of participants. The initial posting was made on June 11th 2020 and editted as recently as January 9th 2022."

Answered by AI

What results are expected to arise from the investigation of this clinical trial?

"This 28-day clinical trial will be assessing the Objective Response rate of patients. Secondary objectives include measuring Overall Survival, Duration of Response and Progression Free Survival via RECIST v1.1 guidelines."

Answered by AI

What is the current capacity of this research study?

"Affirmative. Clinicaltrials.gov reveals that this clinical examination, which was first published on June 11th 2020, is actively enrolling volunteers. Approximately 144 participants must be enrolled from just one medical site."

Answered by AI

What primary purpose does the combination of ARRY-614, nivolumab and ipilimumab (melanoma) serve?

"Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) has been successfully used to treat various conditions, including malignant neoplasms, unresectable melanoma and squamous cell carcinoma. It is especially effective for anti-angiogenic therapy."

Answered by AI
~32 spots leftby Nov 2027