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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Melanoma

Phase 2
Recruiting
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject must have a performance status of 0 or 1 on the ECOG Performance Scale.
The subject must have clinical stage III resectable melanoma per investigator. Subjects may not have a diagnosis of uveal or mucosal melanoma.
Must not have
Has evidence of active interstitial lung disease or a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), interferon, high dose IL-2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat melanoma that has not spread. Subjects will receive neoadjuvant nivolumab, which is a drug that helps the immune system kill cancer cells. Then, they will have surgery to remove the melanoma. After surgery, subjects will receive up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab. This will depend on how well the subject responds to the treatment.

Who is the study for?
Adults over 18 with stage III resectable melanoma can join this trial. They must be in good health, not pregnant or breastfeeding, and willing to use effective contraception. People with certain medical conditions, recent transfusions, active infections, or those on immunosuppressive drugs cannot participate.
What is being tested?
The study tests nivolumab as a pre-surgery (neoadjuvant) treatment for melanoma. After surgery to remove the cancer, patients get either more nivolumab or a combination of nivolumab and ipilimumab for up to one year based on their response to the initial treatment.
What are the potential side effects?
Nivolumab and ipilimumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid), digestive issues (diarrhea/colitis), liver inflammation, and potential lung issues (pneumonitis).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have stage III melanoma that can be surgically removed and it's not in my eyes or mucous membranes.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had lung inflammation that needed steroids.
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I have been treated with specific immune system targeting drugs before.
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I am currently being treated for an infection.
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I have not received a live vaccine in the last 30 days.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence-Free Survival
Secondary study objectives
Frequency and Incidence of Adverse Events
Overall Survival
Pathological 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%
Lipase increased
13%
Pyrexia
12%
Constipation
12%
Aspartate aminotransferase increased
12%
Decreased appetite
12%
Nasopharyngitis
11%
Abdominal pain
11%
Dry mouth
11%
Vomiting
11%
Myalgia
10%
Insomnia
10%
Hypophysitis
10%
Back pain
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%
Colitis
3%
Anxiety
2%
Immune-mediated enterocolitis
2%
Autoimmune hepatitis
2%
Basal cell carcinoma
2%
Malignant neoplasm progression
1%
Squamous cell carcinoma
1%
Autoimmune colitis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C: Adjuvant Combination (Less than Complete Response)Experimental Treatment2 Interventions
ipilimumab (1mg/kg) plus nivolumab (3mg/kg) for 4 doses and then nivolumab (480 mg) alone for a total of one year
Group II: Arm A: Adjuvant Nivolumab (Complete Pathological Response)Active Control1 Intervention
480 mg IV for up to one year
Group III: Arm B: Adjuvant Nivolumab (Less than Complete Response)Active Control1 Intervention
480 mg IV for up to one year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960
Ipilimumab
2014
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
164,580 Total Patients Enrolled
17 Trials studying Melanoma
889 Patients Enrolled for Melanoma
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,453 Total Patients Enrolled
16 Trials studying Melanoma
864 Patients Enrolled for Melanoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04013854 — Phase 2
Melanoma Research Study Groups: Arm C: Adjuvant Combination (Less than Complete Response), Arm A: Adjuvant Nivolumab (Complete Pathological Response), Arm B: Adjuvant Nivolumab (Less than Complete Response)
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04013854 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04013854 — Phase 2
~15 spots leftby Aug 2026
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