Nivolumab + Ipilimumab for Melanoma

Recruiting at 2 trial locations

Overseen By Tara Mitchell

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Immunosuppressants, Steroids, Live vaccines

Disqualifiers: Unresectable disease, Active infection, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

67 Participants Needed

Trial Summary

What is the purpose of this trial?

Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.

Eligibility Criteria

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.

Inclusion Criteria

Either the subject or the subject's legally authorized representative must be willing and able to provide written informed consent before the performance of any protocol-related procedures.

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.

Exclusion Criteria

Prisoners or subjects who are involuntarily incarcerated.

I have or had lung inflammation that needed steroids.

I have been treated with specific immune system targeting drugs before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive one dose of nivolumab 480 mg IV

4 weeks

1 visit (in-person)

Surgery

Participants undergo standard definitive surgery

1 day

1 visit (in-person)

Adjuvant Treatment

Participants receive open-label treatment with nivolumab or ipilimumab plus nivolumab based on pathologic response

1 year

Every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 years

Treatment Details

Interventions

• Ipilimumab
• Nivolumab

Trial Overview 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.

Participant Groups

Group I: Arm C: Adjuvant Combination (Less than Complete Response) Experimental Treatment 2 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 Control 1 Intervention

480 mg IV for up to one year

Group III: Arm B: Adjuvant Nivolumab (Less than Complete Response) Active Control 1 Intervention

480 mg IV for up to one year

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Opdivo for:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+