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Cancer Vaccine

Nivolumab + BCG for High-Risk Bladder Cancer (CheckMate 7G8 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

Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)

Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

CheckMate 7G8 Trial Summary

This trial compares nivolumab, a drug that helps the body's immune system, with bacterial drugs alone in people with high risk bladder cancer.

Who is the study for?

This trial is for people with high-risk bladder cancer that hasn't spread into muscle, who've had a type of treatment called BCG but still have the disease. They should be fairly active and able to care for themselves (ECOG 0-2). People can't join if they have more advanced cancer, including in the upper urinary tract or prostate urethra within specific time frames.Check my eligibility

What is being tested?

The study tests whether adding Nivolumab, an immune system booster, to BCG therapy is better than BCG alone for treating high-risk non-muscle invasive bladder cancer. Participants will either receive Nivolumab plus BCG or a placebo with BCG.See study design

What are the potential side effects?

Nivolumab may cause immune-related side effects such as inflammation in various organs like lungs and intestines, skin issues, hormone gland problems (like thyroid), fatigue, and infusion reactions.

CheckMate 7G8 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My bladder cancer is confirmed to be high-risk but not yet invasive.

Select...

I have completed most of my initial BCG treatment for bladder cancer.

Select...

I can take care of myself and am up and about more than half of the day.

CheckMate 7G8 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 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

Event Free Survival (EFS)

Secondary outcome measures

Complete Response Rate (CRR)

Duration of Response (DOR)

Number of Deaths

+5 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%

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 7G8 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)Experimental Treatment2 Interventions

Group II: Arm B: placebo +BCGPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nivolumab

2016

Completed Phase 3

~4960

Bacillus Calmette-Guérin (BCG)

2014

Completed Phase 2

~1980

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,501 Total Patients Enrolled

Media Library

Bacillus Calmette-Guérin (BCG) (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04149574 — Phase 3

Bladder Cancer Research Study Groups: Arm A: nivolumab + Bacillus Calmette-Guérin (BCG), Arm B: placebo +BCG

Bacillus Calmette-Guérin (BCG) (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04149574 — Phase 3

Bladder Cancer Clinical Trial 2023: Bacillus Calmette-Guérin (BCG) Highlights & Side Effects. Trial Name: NCT04149574 — Phase 3

Frequently Asked Questions

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

What conditions is nivolumab often used to treat?

"Nivolumab is not only used to manage malignant neoplasms, but also other diseases such as unresectable melanoma, squamous cell carcinoma of the skin, and metastatic esophageal adenocarcinoma."

Answered by AI

Is nivolumab a new experimental drug?

"Nivolumab has 747 active clinical trials, with 82 of those in Phase 3. Out of the 40314 total locations conducting studies for nivolumab, many are based in Basel, BE."

Answered by AI

Is this experiment novel in design?

"As of now, there are 747 ongoing clinical trials for nivolumab taking place in 2347 cities and 50 different countries. Nivolumab's first clinical trial was held a decade ago in 2010. The initial study, which127 patients participated in, was sponsored by Medarex and completed Phase 1 drug approval. In the 10 years since that first study, 18531 more have been completed."

Answered by AI

In how many different medical clinics is this study being carried out today?

"There are 6 clinical trial locations for this study, which can be found in Montreal, Levis, Bronx and a few other places. If you decide to enroll in the trial, try to choose the location nearest you to cut down on travel time."

Answered by AI

What is the official government stance on nivolumab's therapeutic properties?

"Our team at Power estimates that nivolumab is safe to use, as it has received a score of 3. This is due to the fact that this medication has gone through Phase 3 trials, meaning there is some data supporting its efficacy and multiple rounds of data supporting its safety."

Answered by AI

Is there still room for people to join this trial?

"Unfortunately, this particular trial is not seeking patients at the moment. Although, it's worth noting that there are 393 other clinical trials for urinary bladder cancer and 747 trials using nivolumab that are actively looking for candidates."

Answered by AI

What is the total number of people that can be in this trial?

"Unfortunately, this particular clinical trial is no longer active. The study was first posted on 1/15/2020 but hasn't been edited in over a year. Although this research project isn't recruiting anymore, there are plenty of other ongoing studies that might be a match for you. For example, right now there are 393 trials involving urinary bladder cancer and 747 trials studying nivolumab that need participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

2020. "A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04149574.

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