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Checkpoint Inhibitor
Nivolumab + Hydroxychloroquine / Ipilimumab for Melanoma (LIMIT Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Ravi Amaravadi, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase 1b nivolumab + ipilimumab + HCQ: anti-PD-1 refractory
At least one measurable site of disease by RECIST 1.1 criteria that has not been previously irradiated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to one year
Awards & highlights
LIMIT Trial Summary
This trial will study whether the addition of HCQ to nivolumab and ipilimumab, or nivolumab alone, improves the safety and effectiveness in people with advanced melanoma.
Who is the study for?
This trial is for adults with advanced melanoma, either Stage III not removable by surgery or Stage IV. They can have any genetic makeup and PD-L1 status, may or may not have had previous treatments, and must be physically well enough to participate (ECOG 0-1). Women must not be pregnant and should test negative for pregnancy. Participants need at least one measurable disease site that hasn't been treated with radiation before.Check my eligibility
What is being tested?
The study tests the combination of hydroxychloroquine with nivolumab alone or together with ipilimumab in patients with advanced melanoma. It aims to assess how safe this mix is, if it's tolerable for patients, and how effective it is at fighting cancer cells.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, skin issues like rash or itching, liver function changes, digestive problems such as nausea or diarrhea, fatigue, muscle aches and pains. The severity of these side effects can vary from person to person.
LIMIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have cancer that did not respond to previous anti-PD-1 therapy.
Select...
I have a cancer spot that can be measured and hasn't been treated with radiation.
Select...
I can take pills and don’t have major stomach or bowel issues affecting drug absorption.
Select...
I can provide tissue samples from my cancer for testing.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
My melanoma cannot be surgically removed and is in Stage III or IV.
Select...
I have had immunotherapy before for my cancer.
LIMIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Maximum tolerated dose (MTD) - Number of Subjects with Dose-limiting Toxicities
Phase 2: Objective Response Rate (ORR)
Secondary outcome measures
1 year survival rate
Progression-free survival
Side effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)
LIMIT Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2: Nivolumab and Hydroxychloroquine (HCQ)Experimental Treatment2 Interventions
HCQ 400-600 mg (maximum tolerated dose from Phase 1a) orally every 12 hours and nivolumab 480 mg IV every 4 weeks
Continue protocol treatment for up to 24 months until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.
Group II: Phase 1b: Nivolumab + Ipilimumab +Hydroxychloroquine (HCQ)Experimental Treatment3 Interventions
HCQ 400-600 mg orally every 12 hours and nivolumab 3 mg/kg IV plus ipilimumab 1 mg/kg IV every 3 weeks x4 cycles
Then 6 weeks after the last dose of ipilimumab/nivolumab begin maintenance nivolumab 480 mg IV every 4 weeks
Continue protocol treatment for up to 24 months until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.
Group III: Phase 1a: Nivolumab and Hydroxychloroquine (HCQ)Experimental Treatment2 Interventions
Dose escalation:
Dose Level 1: HCQ 400 mg orally every 12 hours and nivolumab 480 mg IV every 4 weeks
Dose Level 2: HCQ 600 mg orally every 12 hours and nivolumab 480 mg IV every 4 weeks
Continue protocol treatment for up to 24 months until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
FDA approved
Ipilimumab
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
Ravi Amaravadi, MDLead Sponsor
1 Previous Clinical Trials
173 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,427 Total Patients Enrolled
177 Trials studying Melanoma
57,449 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious infections, illnesses, or psychiatric conditions that would make treatment unsafe for me.My cancer is partially responding to my current immunotherapy treatment.I don't have untreated or unstable brain or spinal cord tumors, and I'm not on high doses of steroids.I have a cancer spot that can be measured and hasn't been treated with radiation.I can take pills and don’t have major stomach or bowel issues affecting drug absorption.All my cancer treatment side effects are mild, except for hair loss.I have or haven't had previous treatments before considering nivolumab + HCQ.I have cancer that did not respond to previous anti-PD-1 therapy.You need to have a negative pregnancy test within 24 hours before starting the treatment.I have not been treated with anti-PD-1 antibodies but may have had other treatments.I am fully active or have some restrictions but can still care for myself.I can provide tissue samples from my cancer for testing.You have had a bad reaction to drugs similar to the study drug or its ingredients.I am not taking any medications that are not allowed in the study.You have porphyria or psoriasis, but it must be well controlled and monitored by a specialist.I have not taken seizure medication that affects liver enzymes in the last 4 weeks.If you are a woman who can still have babies, you need to have a negative pregnancy test within 28 days before starting the treatment.I haven't had cancer, other than skin cancer or slow-growing cancer, in the last 3 years.My melanoma cannot be surgically removed and is in Stage III or IV.I have a history of heart problems or am at high risk for them.My organs are functioning well.I have a severe autoimmune disease and take medication to suppress my immune system.I have a history of lung scarring or inflammation not caused by previous immune treatments.I have had immunotherapy before for my cancer.I haven't had cancer treatment or experimental drugs in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Nivolumab + Ipilimumab +Hydroxychloroquine (HCQ)
- Group 2: Phase 2: Nivolumab and Hydroxychloroquine (HCQ)
- Group 3: Phase 1a: Nivolumab and Hydroxychloroquine (HCQ)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
What are the main medical conditions that Hydroxychloroquine is used to manage?
"Hydroxychloroquine can be used to combat malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Are we still able to enroll patients in this clinical trial?
"That is accurate. The clinical trial's listing on clinicaltrials.gov shows that the study is still looking for patients to participate. Originally posted on October 21st 2020, the information was updated September 15th 2021. So far, 94 people between 1 locations have signed up."
Answered by AI
How many people are receiving care as part of this research?
"That is accurate. The clinical trial mentioned is currently underway, with the original posting date being October 21st 2020. As of September 15th 2021, 94 patients have been enrolled at a single location."
Answered by AI
Are there any other previous experiments that have looked at Hydroxychloroquine?
"At this time, 860 studies are being conducted to research hydroxychloroquine. Of these active trials, 93 are in phase 3. The majority of the investigations for hydroxychloroquine are based in Pittsburgh, Pennsylvania; however, there are a total of 44081 locations running trials for this treatment worldwide."
Answered by AI
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