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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

Must not have

Metastases limited to head and neck or lungs/hilar lymph nodes

Uncontrolled intercurrent illnesses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread only to my head, neck, or lung area.

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I do not have any uncontrolled illnesses.

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My cancer is a type of eye melanoma that has spread.

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I have had a stem cell or organ transplant.

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I have brain metastases that haven't been treated.

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My cancer spread cannot be treated with lymphatic infusion.

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I am HIV positive and on antiretroviral therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Maximum tolerated dose (MTD) of ipilimumab administration via the DoseConnect device in combination with nivolumab

Overall survival

+1 more

Other study objectives

Immune parameter analysis

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~3070

Nivolumab

2015

Completed Phase 3

~4010