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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Uveal Melanoma

Phase 2

Waitlist Available

Led By Sapna Patel

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 40 mL/min (using the Cockcroft-Gault formula)

Performance status Eastern Cooperative Oncology Group (ECOG) 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 1 year

Awards & highlights

Study Summary

This trial tests using nivolumab and ipilimumab to treat metastatic uveal melanoma, to help the body fight the cancer.

Who is the study for?

This trial is for adults with metastatic uveal melanoma, who've waited enough time after previous treatments and surgeries. They must have at least one measurable cancer lesion, be in good physical condition (ECOG 0-1), and not be pregnant or breastfeeding. Contraception is required to prevent pregnancy during the study. People with certain medical conditions, untreated primary uveal melanoma, other recent cancers, autoimmune diseases, or those on conflicting medications are excluded.Check my eligibility

What is being tested?

The trial tests nivolumab and ipilimumab—two immunotherapy drugs—to see how well they treat metastatic uveal melanoma by helping the immune system attack cancer cells. It's a phase II study which means it focuses on the effectiveness of these drugs when given together.See study design

What are the potential side effects?

Nivolumab and Ipilimumab can cause side effects like fatigue, diarrhea, skin issues (like rash), hormone gland problems (like thyroid dysfunction), liver inflammation, and other immune-related conditions that may affect organs such as lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I am fully active or can carry out light work.

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I have uveal melanoma with a tumor that is at least 1 cm big.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate, Defined Per RECIST 1.1

Secondary outcome measures

1-year Overall Survival

Overall Survival

Progression-Free Survival

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

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, ipilimumab)Experimental Treatment3 Interventions

INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

FDA approved

Nivolumab

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,735 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,600 Total Patients Enrolled

Sapna PatelPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

1,400 Total Patients Enrolled

Frequently Asked Questions

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

Has Ipilimumab been granted regulatory authorization from the FDA?

"The clinical trial for Ipilimumab is still in Phase 2, so it only has evidence to support its safety rather than efficacy. Our team at Power decided that this warranted a score of two when assessing the drug's security levels."

Answered by AI

Is recruitment for this clinical research still in progress?

"According to the data on clinicaltrials.gov, this specific medical trial is no longer recruiting patients and hasn't done so since September 18th 2023. However, there are still 735 other active studies that are looking for new participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma

2012. "Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01585194.