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Checkpoint Inhibitor

Immunotherapy After Surgery for Kidney Cancer (CheckMate 914 Trial)

Phase 3

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 10 years

Awards & highlights

CheckMate 914 Trial Summary

This trial will test whether two immunotherapy drugs can prevent kidney cancer from recurring after surgery.

Who is the study for?

This trial is for individuals who've had kidney cancer surgery with no remaining visible cancer. They must have had the surgery within 4-12 weeks before joining, have a specific type of kidney cancer (clear cell RCC), and be generally healthy (ECOG 0-1). Women should agree to use contraception. People can't join if they've recently had certain vaccines, autoimmune diseases, HIV/AIDS, previous treatments affecting immune response, severe health conditions or allergies to study drugs.Check my eligibility

What is being tested?

The study tests whether Nivolumab alone or combined with Ipilimumab prevents kidney cancer from coming back after part of a kidney has been removed due to cancer. Participants will randomly receive either the actual drugs or placebos (inactive substances) to compare effectiveness and safety.See study design

What are the potential side effects?

Nivolumab and Ipilimumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, hormone gland problems like thyroid issues, digestive tract symptoms like diarrhea or liver inflammation, lung issues like shortness of breath or coughing.

CheckMate 914 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Disease-free survival (DFS) as assessed by BICR (Part A and Part B)

Secondary outcome measures

Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C)

Incidence of Adverse Events (AEs) (Part A and Part B)

Overall Survival (OS) (Part A and Part B)

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%

Insomnia

10%

Back pain

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 914 Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B, Arm C: nivolumab + ipilimumab placeboExperimental Treatment3 Interventions

Group II: Part B, Arm A: nivolumab + ipilimumabExperimental Treatment3 Interventions

Group III: Part A, Arm A: nivolumab + ipilimumabExperimental Treatment2 Interventions

Group IV: Part A, Arm B: nivolumab placebo + ipilimumab placeboPlacebo Group2 Interventions

Group V: Part B, Arm B: nivolumab placebo + ipilimumab placeboPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nivolumab

2016

Completed Phase 3

~4960

ipilimumab

2016

Completed Phase 3

~5520

nivolumab placebo

2017

Completed Phase 3

~2180

ipilimumab placebo

2017

Completed Phase 3

~1660

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,126,861 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03138512 — Phase 3

Renal Cell Carcinoma Research Study Groups: Part A, Arm A: nivolumab + ipilimumab, Part A, Arm B: nivolumab placebo + ipilimumab placebo, Part B, Arm A: nivolumab + ipilimumab, Part B, Arm B: nivolumab placebo + ipilimumab placebo, Part B, Arm C: nivolumab + ipilimumab placebo

Renal Cell Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03138512 — Phase 3

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03138512 — Phase 3

Frequently Asked Questions

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

Can you name a few other research projects which have used nivolumab?

"nivolumab was first used in 2009 in Texas Children's Hospital. Out of the 800 active clinical trials being performed with nivolumab, 351 have been completed. Many of these studies originate from Aurora, Colorado."

Answered by AI

For what purpose is nivolumab most commonly used?

"Nivolumab is often given to patients who have not responded well to anti-angiogenic therapy in the past. That being said, it has also been shown to be effective at treating malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Can people with the required qualifications enroll in this trial today?

"This particular trial is not admitting any more patients at this time. The posting dates for this trial were from July 7th, 2017 to October 19th, 2020. However, there are still 2655 trials for carcinoma, renal cell and 800 trials for nivolumab that are admitting patients."

Answered by AI

Has the Federal Drug Administration given nivolumab the okay for general use?

"There is some efficacy data and multiple rounds of safety data, which is typical for a Phase 3 trial. Therefore, nivolumab receives a score of 3 for safety."

Answered by AI

How many institutions are participating in this experiment?

"This trial is enrolling patients at 47 sites. The locations are situated in Aurora, Springdale and Fairfax as well as other cities. If you enroll, it might be helpful to select the site nearest to you to reduce travel time."

Answered by AI

Recent research and studies

Clinical Genitourinary CancerJournal

Prevalence, Disease-free, and Overall Survival of Contemporary Patients with Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials

Marconi, Lorenzo, Maxine Sun, Christian Beisland, Tobias Klatte, Boerje Ljungberg, Grant D. Stewart, Saeed Dabestani, Toni K. Choueiri, and Axel Bex. 2021. “Prevalence, Disease-free, and Overall Survival of Contemporary Patients with Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials”. Clinical Genitourinary Cancer. Elsevier BV. doi:10.1016/j.clgc.2020.12.005.

clinicaltrials.govStudy

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

2017. "A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03138512.