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Checkpoint Inhibitor

Ipilimumab + Nivolumab for Advanced Skin Cancer

Phase 1

Waitlist Available

Led By Anastasios Dimou, M.D.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Pain in extremity

Weight decreased

Leukopenia

Alanine aminotransferase increased

Hyponatraemia

Pneumonia

Haemoglobin decreased

Neutrophil count decreased

Dizziness

Malignant neoplasm progression

Aspartate aminotransferase increased

Bone pain

Haemoptysis

Back pain

Headache

Hypomagnesaemia

Stomatitis

Abdominal pain upper

Oedema peripheral

White blood cell count decreased

Chest pain

Dehydration

Abdominal pain

Febrile neutropenia

Paraesthesia

Musculoskeletal pain

Colitis

Death

Lung infection

Pulmonary embolism

Mucosal inflammation

Multi-organ failure

Cerebrovascular accident

Lung neoplasm malignant

Lung abscess

General physical health deterioration

Interstitial lung disease

Liver function test abnormal

Sudden death

Chronic obstructive pulmonary disease

Metastases to central nervous system

Blood creatinine increased

Atrial fibrillation

Cardio-respiratory arrest

Confusional state

Intestinal perforation

Pulmonary haemorrhage

Drug hypersensitivity

Infection

Pneumothorax

Renal failure

Lower respiratory tract infection

Pain

Respiratory failure

Syncope

Hyperglycaemia

Sepsis

Acute kidney injury

Hypersensitivity

Urinary tract infection

Disease progression

Pneumonitis

100%

80%

60%

40%

20%

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

~2620

Nivolumab

2014

Completed Phase 3

~4750

Biospecimen Collection

2004

Completed Phase 2

~1730

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,134 Total Patients Enrolled

40 Trials studying Melanoma

2,517 Patients Enrolled for Melanoma

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,675 Total Patients Enrolled

557 Trials studying Melanoma

193,227 Patients Enrolled for Melanoma

Anastasios Dimou, M.D.Principal InvestigatorMayo Clinic in Rochester

1 Previous Clinical Trials

3 Total Patients Enrolled

1 Trials studying Melanoma

3 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04967196 — Phase 1

Melanoma Research Study Groups: Cohort A (ipilimumab DC and IV, nivolumab) CLOSED, Cohort B (Ipilimumab DC and nivolumab IV)

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this research endeavor?

"Affirmative. According to information posted on clinicaltrials.gov, this medical study is currently open for enrollment and was first made available to the public on September 16th 2021. 18 patients are needed at one site; the trial's details were last updated in May 6th 2022."

Answered by AI

Has the Food and Drug Administration green-lit Ipilimumab as a therapeutic agent?

"Our team at Power judged the safety of Ipilimumab to be a 1, since this Phase 1 trial has only provided limited evidence for both its efficacy and security."

Answered by AI

For what symptoms is Ipilimumab typically prescribed?

"Ipilimumab is primarily used to help counteract the effects of anti-angiogenic therapy. Additionally, it has been proven to treat cases of malignant neoplasms, advanced melanoma, and squamous cell carcinomas."

Answered by AI

Is the opportunity to participate in this experiment still available?

"As per the information on clinicaltrials.gov, this research is still open to enrolment and was originally posted on September 16th 2021 with a final update made in May 6th 2022."

Answered by AI

Has Ipilimumab been explored in any other research investigations?

"As of now, there are 764 active studies investigating Ipilimumab's efficacy with 86 Phase 3 trials. Primarily centred in Pittsburgh, Pennsylvania, a total 42751 medical centres around the world are running research projects related to this drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma

2021. "Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04967196.

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