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Checkpoint Inhibitor

Ipilimumab + Nivolumab for Advanced Skin Cancer

Phase 1
Waitlist Available
Led By Svetomir N Markovic
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed diagnosis of unresectable stage III or IV metastatic melanoma meeting specific criteria
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new way to give immunotherapy to people with melanoma that has spread.

Who is the study for?
Adults with stage III-IV melanoma that can't be surgically removed or has spread, who have proper liver and kidney function, no severe diseases that could interfere with the trial, not pregnant or nursing, willing to use contraception for 6 months post-treatment. Excludes those with certain metastases locations, active brain metastases not treated previously, HIV on antiretrovirals, history of severe autoimmune disease or hypersensitivity to study drugs.Check my eligibility
What is being tested?
The trial is testing the optimal dose of ipilimumab administered through DoseConnect followed by nivolumab. These are monoclonal antibodies designed to boost the immune system's ability to fight cancer and prevent tumor growth in patients with advanced melanoma.See study design
What are the potential side effects?
Ipilimumab and Nivolumab may cause immune-related side effects such as inflammation in various organs including skin rashes and digestive issues; they might also lead to fatigue and allergic reactions related to infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma is at an advanced stage and cannot be surgically removed.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My blood clotting tests are within the normal range or target if I'm on blood thinners.
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My kidneys are functioning well enough, based on a specific test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Incidence of adverse events
Maximum tolerated dose (MTD) of ipilimumab administration via the DoseConnect device in combination with nivolumab
Overall survival
+1 more
Other outcome measures
Immune parameter analysis

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B (Ipilimumab DC and nivolumab IV)Experimental Treatment4 Interventions
Patients receive ipilimumab intra-lymphatically via DoseConnect™ and nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study and may optionally undergo lymphatic imaging with ICG prior to treatment start.
Group II: Cohort A (ipilimumab DC and IV, nivolumab) CLOSEDExperimental Treatment4 Interventions
Patients receive ipilimumab intra-lymphatically via DoseConnect™ on day 1 of cycle 1 and IV over 30 minutes on day 1 of cycles 2-4. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo lymphatic imaging with ICG prior to treatment start and blood sample collection throughout the study. (CLOSED TO ENROLLMENT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4750
Biospecimen Collection
2004
Completed Phase 2
~1720

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,242 Previous Clinical Trials
3,773,743 Total Patients Enrolled
41 Trials studying Melanoma
2,547 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,357 Total Patients Enrolled
559 Trials studying Melanoma
195,436 Patients Enrolled for Melanoma
Svetomir N MarkovicPrincipal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
548 Total Patients Enrolled
3 Trials studying Melanoma
548 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04967196 — Phase 1
Melanoma Research Study Groups: Cohort B (Ipilimumab DC and nivolumab IV), Cohort A (ipilimumab DC and IV, nivolumab) CLOSED
Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04967196 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04967196 — Phase 1
~0 spots leftby Jul 2024
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