Your session is about to expire
← Back to Search
Other
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 belowSelect...
I am 18 years old or older.
Select...
My bone marrow is working well.
Select...
I can receive nivolumab or ipilimumab therapy, and it's suitable for my condition.
Select...
My cancer is advanced, cannot be surgically removed, and cannot be cured with existing treatments.
Select...
My kidneys are functioning well enough (creatinine clearance > 30 mL/min).
Select...
My melanoma/RCC/NSCLC/HNSCC progressed despite anti-PD1 treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am a woman who can have children and have a negative pregnancy test before starting treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
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 moreOther 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
Eligibility Criteria:
This trial includes the following eligibility 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.I have another type of cancer that needs treatment.I have a condition that affects how my body absorbs medication taken by mouth.I am 18 years old or older.I do not have an active infection needing antibiotics or a fever over 38.5°C in the last week.I have an active hepatitis B or C infection.I need steroids for my brain cancer symptoms.I am currently institutionalized by court or administrative order.I have never needed steroids for non-infectious lung inflammation.My bone marrow is working well.I have had serious heart problems in the last 6 months.I had major surgery less than 4 weeks ago or am still recovering from surgery side effects.I can receive nivolumab or ipilimumab therapy, and it's suitable for my condition.My cancer is advanced, cannot be surgically removed, and cannot be cured with existing treatments.You have at least one visible and measurable tumor according to specific guidelines.I haven't had cancer treatment or experimental drugs in the last 2 weeks.People with HIV can join the study if they meet certain requirements.I am allergic to ARRY-614 or anti-PD1/ipilimumab treatments.My kidneys are functioning well enough (creatinine clearance > 30 mL/min).My melanoma/RCC/NSCLC/HNSCC progressed despite anti-PD1 treatment.I haven't received any cancer antibody treatments in the last 4 weeks.I do not have any health or mental conditions that could make this study unsafe for me.Your heart's pumping ability is less than 40% based on a recent ECHO scan.I have recovered from side effects of previous cancer treatments, or they are manageable.I haven't needed treatment for an autoimmune disease in the last 2 years.I had liver treatments like radiation or ablation less than 4 weeks ago.I am not immunodeficient and do not take more than 10 mg of prednisone or its equivalent daily.I do not have an active lung condition involving scarring.I am fully active or restricted in physically strenuous activity but can do light work.My liver is working well.I am a woman who can have children and have a negative pregnancy test before starting treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II ARRY-614 + nivolumab
- Group 2: Phase Ib ARRY-614 + nivolumab
- Group 3: Phase Ib ARRY-614 + nivolumab + ipilimumab
- Group 4: Phase II ARRY-614 + nivolumab + ipilimumab (melanoma)
- Group 5: Phase II ARRY-614 + nivolumab + ipilimumab (RCC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger