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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
Renal System: Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR ≥50 mL/min for subject with creatinine levels >1.5 X institutional ULN
Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 7 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Melanoma Stage III
  • Melanoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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

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 • 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%
Hypophysitis
10%
Back pain
10%
Insomnia
9%
Amylase increased
8%
Dyspnoea
8%
Upper respiratory tract infection
7%
Dizziness
6%
Abdominal pain upper
6%
Adrenal insufficiency
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

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
~2820
Ipilimumab
2014
Completed Phase 3
~2690

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
374 Previous Clinical Trials
117,487 Total Patients Enrolled
16 Trials studying Melanoma
841 Patients Enrolled for Melanoma
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,097 Total Patients Enrolled
16 Trials studying Melanoma
841 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

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
Recent research and studies
~24 spots leftby Aug 2026