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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have stage III melanoma that can be surgically removed and it's not in my eyes or mucous membranes.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-Free Survival
Secondary outcome measures
Frequency and Incidence of Adverse Events
Overall Survival
Pathological Response Rate
Side effects data
From 2021 Phase 3 trial • 1844 Patients • NCT0306845538%
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%
Hypophysitis
10%
Insomnia
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%
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
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
~2620
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,604 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
105,004 Total Patients Enrolled
16 Trials studying Melanoma
864 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had lung inflammation that needed steroids.I have been treated with specific immune system targeting drugs before.I am currently being treated for an infection.I have another cancer besides the one being studied, but it's not getting worse or needing treatment.I am fully active or restricted in physically strenuous activity but can do light work.I agree to follow the study's contraceptive advice for 7 months after my last medication dose.I have not received blood products or specific medications to stimulate blood cell production within the last 4 weeks.I have recovered from any major surgery before starting the study treatment.I have not had any cancer treatment or experimental drugs in the last 4 weeks.I have stage III melanoma that can be surgically removed and it's not in my eyes or mucous membranes.I have taken a pregnancy test in the last 72 hours and it was negative.I am not pregnant or breastfeeding and either cannot become pregnant or will follow strict birth control measures.You have HIV and your CD4 count is less than 350 mm3 and your HIV viral load is more than 25,000 IU/mL.You are required to stay in a hospital for treatment of a psychiatric or physical illness.My melanoma cannot be fully removed by surgery.I am 18 years old or older.I have not received a live vaccine in the last 30 days.I haven't needed systemic treatment for an autoimmune disease in the last 3 months.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.You have a current Hepatitis B or Hepatitis C infection.My organ functions are within the required range for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C: Adjuvant Combination (Less than Complete Response)
- Group 2: Arm A: Adjuvant Nivolumab (Complete Pathological Response)
- Group 3: Arm B: Adjuvant Nivolumab (Less than Complete Response)
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 still opportunities to join this experiment?
"This clinical trial is currently open to participants, with the original posting on January 1st 2020 and a subsequent update made in March 25th 2022. This information can be found via a search of clinicaltrials.gov."
Answered by AI
What medical conditions might prompt a doctor to prescribe nivolumab?
"Nivolumab is typically used for patients who have undergone angiogenic therapies, but can also be effective when treating malignant neoplasms, unresectable melanoma, and squamous cell carcinomas."
Answered by AI
What is the current enrollment capacity for this clinical trial?
"Affirmative. Information published on clinicaltrials.gov states that this study, which was initially posted in January of 2020, is actively recruiting candidates. At present, 60 individuals need to be enrolled from two distinct sites."
Answered by AI
Has the Food and Drug Administration sanctioned nivolumab for therapeutic use?
"Nivolumab was rated 2 on our safety scale, as there is some evidence of the drug's security but no proof demonstrating its efficiency."
Answered by AI
Have any other scientific investigations been conducted regarding nivolumab?
"In 2009, nivolumab was first studied at Texas Children's Hospital. Since then, 363 trials have been completed and 764 are in progress, with many of them occurring in Philadelphia."
Answered by AI
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