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Checkpoint Inhibitor

Ipilimumab + Nivolumab for Melanoma

Phase 2
Waitlist Available
Led By Michael Postow, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic diagnosis of unresectable III or stage IV metastatic melanoma
No prior CTLA-4 or PD-1/PD-L1 therapy for the treatment of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 weeks
Awards & highlights

Study Summary

This trial will help determine if two doses of the combination of ipilimumab and nivolumab is sufficient for patients with early benefit, compared to the usual way of trying to give four doses.

Who is the study for?
This trial is for adults with unresectable stage III or IV melanoma who haven't had CTLA-4 or PD-1/PD-L1 therapy. They must have a life expectancy of at least 4 months, be in good physical condition (ECOG 0-1), and women must use effective contraception. Exclusions include severe allergies, mental impairments, other serious illnesses, active autoimmune diseases requiring steroids or immunosuppressants, certain neuropathies, another active cancer, known immunodeficiency or viral hepatitis.Check my eligibility
What is being tested?
The study tests if two doses of ipilimumab plus nivolumab are as effective as the usual four doses for patients showing early benefits from treatment. Patients without early benefit can continue receiving additional doses beyond the standard four if deemed beneficial.See study design
What are the potential side effects?
Ipilimumab and nivolumab may cause immune-related side effects such as inflammation in various organs including the intestines and liver, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, and can increase susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma cannot be removed by surgery and is stage III or IV.
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I haven't received CTLA-4 or PD-1/PD-L1 therapy for my metastatic disease.
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My blood tests meet the required levels, and I am 18 or older.
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I use two birth control methods and will continue for 23 weeks after my last treatment dose.
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I am fully active or can carry out light work.
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I have at least one tumor outside the brain that can't be removed surgically and can be measured on scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks 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 rate

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455
38%
Fatigue
37%
Diarrhoea
37%
Pruritus
29%
Headache
28%
Rash
24%
Hypothyroidism
24%
Nausea
20%
Hyperthyroidism
18%
Arthralgia
18%
Cough
18%
Asthenia
15%
Alanine aminotransferase increased
13%
Pyrexia
13%
Lipase increased
12%
Constipation
12%
Aspartate aminotransferase increased
12%
Decreased appetite
12%
Nasopharyngitis
11%
Abdominal pain
11%
Dry mouth
11%
Vomiting
11%
Myalgia
10%
Back pain
10%
Insomnia
10%
Hypophysitis
9%
Amylase increased
8%
Dyspnoea
8%
Upper respiratory tract infection
7%
Dizziness
6%
Adrenal insufficiency
6%
Abdominal pain upper
6%
Infusion related reaction
6%
Hyperglycaemia
6%
Oropharyngeal pain
6%
Blood creatine phosphokinase increased
6%
Influenza like illness
5%
Vitiligo
5%
Hypertension
5%
Pain in extremity
3%
Anxiety
3%
Colitis
2%
Immune-mediated enterocolitis
2%
Autoimmune hepatitis
2%
Basal cell carcinoma
2%
Malignant neoplasm progression
1%
Autoimmune colitis
1%
Squamous cell carcinoma
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Erysipelas
1%
Pneumonia
1%
Melanoma recurrent
1%
Pneumonitis
1%
Sarcoidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Ipi
Arm B: Nivo

Trial Design

1Treatment groups
Experimental Treatment
Group I: ipilimumab and nivolumabExperimental Treatment2 Interventions
Pts will receive 2 doses of ipilimumab 3mg/kg + nivolumab 1mg/kg every 3 weeks. Week 6, if pts have achieved a favorable antitumor effect by RECIST will begin maintenance nivolumab alone at 480mg every 4 weeks for 2 doses (week 6 & week 10) & repeat response assessments at week 12. If pts don't achieve a favorable antitumor effect at week 6, pt will get 2 additional doses of ipilimumab + nivolumab every 3 weeks & then will be assessed for response at week 12. If pts haven't achieved a favorable antitumor effect by week 12, if felt in the best interest for the pt as determined by the PI, pts may continue getting additional doses of ipilimumab + nivolumab with response reassessments after every 2 doses. Maintenance nivolumab will continued until unacceptable toxicity or confirmed disease progression. If pts have had an initial clinical benefit from therapy & subsequently experience progressive disease at any time, reinduction with combination ipilimuma+ nivolumab will be allowed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ipilimumab
2016
Completed Phase 3
~5520
nivolumab
2016
Completed Phase 3
~4960

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,738 Total Patients Enrolled
76 Trials studying Melanoma
15,908 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,466 Total Patients Enrolled
177 Trials studying Melanoma
57,496 Patients Enrolled for Melanoma
Michael Postow, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
123 Total Patients Enrolled
5 Trials studying Melanoma
123 Patients Enrolled for Melanoma

Media Library

Ipilimumab and Nivolumab Combination Immunotherapy (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03122522 — Phase 2
Melanoma Research Study Groups: ipilimumab and nivolumab
Melanoma Clinical Trial 2023: Ipilimumab and Nivolumab Combination Immunotherapy Highlights & Side Effects. Trial Name: NCT03122522 — Phase 2
Ipilimumab and Nivolumab Combination Immunotherapy (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03122522 — Phase 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 analogous trials with ipilimumab previously conducted?

"As of now, 765 studies are currently investigating ipilimumab with 86 trials in their final stage. Although many medical centres based in Pittsburgh, Pennsylvania have conducted research on this drug, there exist 42707 other locations devoted to its clinical trial."

Answered by AI

To what extent is this medical research being conducted in North America?

"This medical trial is actively enrolling patients at Lehigh Valley Health Network in Allentown, Pennsylvania, Hartford Healthcare Cancer Institute @ Hartford Hospital in Hartford, Connecticut and Memoral Sloan Kettering Basking Ridge in Basking Ridge, New york. An additional 12 sites are also available for data collection."

Answered by AI

For what health concerns is ipilimumab usually prescribed?

"Ipilimumab can be employed to ameliorate the effects of previous angiogenic therapy, malignant growths, and inoperable melanoma."

Answered by AI

What is the current scale of this medical trial’s cohort?

"This trial is not presently seeking new participants. It was initially listed on April 17th 2017, and last updated on March 10th 2022. Should you wish to explore alternative studies, there are 765 trials that accept metastatic melanoma patients and an additional 765 clinical trials involving ipilimumab currently recruiting individuals."

Answered by AI

Are new participants being recruited for this investigation?

"This trial is not actively accepting patients at this point in time. The posting date was April 17th, 2017 and it has been revised as recently as March 10th 2022. Other relevant studies include 765 trails for metastatic melanoma and an additional 765 trials recruiting participants who wish to utilize ipilimumab treatment."

Answered by AI

Is ipilimumab deemed a secure treatment option for individuals?

"The safety of ipilimumab is rated 2 on our team's rating scale as it has progressed to Phase 2 clinical trials, showcasing some evidence for its safety but none pertaining to efficacy."

Answered by AI
~0 spots leftby Apr 2024