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Checkpoint Inhibitor

ipilimumab for Tumors (CheckMate 76U Trial)

Phase 1

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

CheckMate 76U Trial Summary

This trial looks at the effectiveness of two drugs, ipilimumab and nivolumab, when used alone or in combination to treat various types of cancer.

CheckMate 76U Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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

Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)

Upper arm

Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)

+12 more

Secondary outcome measures

Incidence of AE's leading to discontinuation

Incidence of adverse events (AE's)

Incidence of death

+15 more

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455

38%

Fatigue

37%

Diarrhoea

37%

Pruritus

29%

Headache

28%

Rash

24%

Hypothyroidism

24%

Nausea

20%

Hyperthyroidism

18%

Arthralgia

18%

Cough

18%

Asthenia

15%

Alanine aminotransferase increased

13%

Lipase increased

13%

Pyrexia

12%

Constipation

12%

Aspartate aminotransferase increased

12%

Decreased appetite

12%

Nasopharyngitis

11%

Abdominal pain

11%

Dry mouth

11%

Vomiting

11%

Myalgia

10%

Hypophysitis

10%

Back pain

10%

Insomnia

Amylase increased

Dyspnoea

Upper respiratory tract infection

Dizziness

Adrenal insufficiency

Abdominal pain upper

Infusion related reaction

Hyperglycaemia

Oropharyngeal pain

Blood creatine phosphokinase increased

Influenza like illness

Vitiligo

Hypertension

Pain in extremity

Colitis

Anxiety

Immune-mediated enterocolitis

Autoimmune hepatitis

Basal cell carcinoma

Malignant neoplasm progression

Autoimmune colitis

Squamous cell carcinoma

Hepatitis

Immune-mediated hepatitis

Erysipelas

Pneumonia

Melanoma recurrent

Pneumonitis

Sarcoidosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Nivo + Ipi

Arm B: Nivo

CheckMate 76U Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: Arm B: RCCExperimental Treatment3 Interventions

advanced or metastatic renal cell carcinoma (RCC)

Group II: Part 2: Arm A: NSCLCExperimental Treatment3 Interventions

metastatic non small cell lung cancer (NSCLC)

Group III: Part 1: Arm B: mMExperimental Treatment2 Interventions

metastatic Melanoma (mM)

Group IV: Part 1 Arm A: mM, mUC, HCCExperimental Treatment3 Interventions

metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ipilimumab

2016

Completed Phase 3

~5520

nivolumab

2016

Completed Phase 3

~4960

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,634 Previous Clinical Trials

4,126,834 Total Patients Enrolled

11 Trials studying Tumors

2,107 Patients Enrolled for Tumors

Frequently Asked Questions

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

What is the current participant capacity of this clinical experiment?

"This medical research is no longer enrolling patients; the study was initially posted on June 25th 2020, and per its latest update was edited November 16th 2021. Fortunately, there are presently 30 studies seeking participants with tumors and 799 clinical trials utilizing ipilimumab actively recruiting subjects."

Answered by AI

Has the FDA sanctioned ipilimumab for use?

"The safety of ipilimumab is thought to be moderate, earning a score of 1. This assessment derives from the fact that this research is in its first stage, with limited clinical data currently available on efficacy and security."

Answered by AI

In what medical instances is ipilimumab typically employed?

"ipilimumab is a popular treatment for neoplasia. It has also been used to combat unresectable melanoma, squamous cell carcinoma and drug extravasation in certain patients."

Answered by AI

What other explorations of ipilimumab have been undertaken in the past?

"Ipilimumab was first studied in 2009 at Texas Children's Hospital, and has since been the subject of 407 clinical trials. Presently, 799 ipilimumab studies are actively recruiting volunteers with a number of these research projects being conducted from Fort Wayne, Indiana."

Answered by AI

Are there any current openings in this clinical experiment?

"Clinicaltrials.gov indicates that this trial, which was first posted on June 25th 2020 and last updated on November 16th 2021, is not currently seeking enrollees. However, there are 829 other studies actively recruiting patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types

2020. "A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04311710.