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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

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

Amylase increased

Dyspnoea

Upper respiratory tract infection

Dizziness

Abdominal pain upper

Adrenal insufficiency

Infusion related reaction

Hyperglycaemia

Oropharyngeal pain

Blood creatine phosphokinase increased

Influenza like illness

Vitiligo

Hypertension

Pain in extremity

Colitis

Anxiety

Immune-mediated enterocolitis

Autoimmune hepatitis

Basal cell carcinoma

Malignant neoplasm progression

Autoimmune colitis

Squamous cell carcinoma

Hepatitis

Immune-mediated hepatitis

Erysipelas

Pneumonia

Melanoma recurrent

Pneumonitis

Sarcoidosis

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met

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

New England Journal of MedicineJournal

Adjuvant Nivolumab Versus Ipilimumab in Resected Stage III or IV Melanoma

Weber, Jeffrey, Mario Mandala, Michele Del Vecchio, Helen J. Gogas, Ana M. Arance, C. Lance Cowey, Stéphane Dalle, et al.. 2017. “Adjuvant Nivolumab Versus Ipilimumab in Resected Stage III or IV Melanoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1709030.

New England Journal of MedicineJournal

Adjuvant Pembrolizumab Versus Placebo in Resected Stage III Melanoma

Eggermont, Alexander M.M., Christian U. Blank, Mario Mandala, Georgina V. Long, Victoria Atkinson, Stéphane Dalle, Andrew Haydon, et al.. 2018. “Adjuvant Pembrolizumab Versus Placebo in Resected Stage III Melanoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1802357.

Nature MedicineJournal

A Single Dose of Neoadjuvant PD-1 Blockade Predicts Clinical Outcomes in Resectable Melanoma

Huang, Alexander C., Robert J. Orlowski, Xiaowei Xu, Rosemarie Mick, Sangeeth M. George, Patrick K. Yan, Sasikanth Manne, et al.. 2019. “A Single Dose of Neoadjuvant PD-1 Blockade Predicts Clinical Outcomes in Resectable Melanoma”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-019-0357-y.

clinicaltrials.govStudy