← Back to Search

Cancer Vaccine

Intravenous MK-3475/ Intravesical BCG for Bladder Cancer (MARC Trial)

Phase 1

Waitlist Available

Led By Krishna Rao, MD

Research Sponsored by Southern Illinois University

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 change from baseline to 23 weeks

Awards & highlights

MARC Trial Summary

This trial is testing a new treatment for bladder cancer that has not yet spread. The treatment is a combination of two drugs, and this trial is testing to see if it is safe and effective.

Eligible Conditions

Bladder Cancer

MARC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 23 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 23 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 23 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

safety (Grade and quantity of adverse events)

Secondary outcome measures

Complete Response Rate (cytoscopy)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

MARC Trial Design

1Treatment groups

Experimental Treatment

Group I: Intravenous MK-3475/ Intravesical BCGExperimental Treatment1 Intervention

3 subjects will be treated at a dose of 100 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses 12 subjects will be treated at a dose of 200 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Southern Illinois UniversityLead Sponsor

36 Previous Clinical Trials

15,238 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,878 Previous Clinical Trials

5,053,184 Total Patients Enrolled

Krishna Rao, MDPrincipal InvestigatorSouthern Illinois University

Frequently Asked Questions

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

How many participants have been recruited for this clinical research endeavor?

"This clinical trial is not accepting new participants currently. It was published on June 1st 2015 and last edited on May 21st 2021. However, 373 trials recruiting patients with urinary bladder cancer are actively enrolling as well as 963 studies employing the MK-3475 intravenous/intravesical BCG combination therapy seeking volunteers."

Answered by AI

Are there any available slots remaining for the trial?

"The clinical trial data hosted on the website clinicialtrials.gov reveals that this particular research project is no longer actively recruiting participants, as it was last updated in May 2021 and initially posted in June 2015. However, there are presently 1336 other medical trials searching for patients at this time."

Answered by AI

Are there any prior studies of the combination of Intravenous MK-3475 and Intravesical BCG?

"Presently, there are 963 active medical trials focused on Intravenous MK-3475/ Intravesical BCG. Of these investigations, 122 have reached Phase 3. Although Houston, Texas is the main hub for this treatment investigation, it can be accessed in 35772 locations around the world."

Answered by AI

Has the FDA authorized the usage of Intravenous MK-3475/Intravesical BCG?

"Our team at Power considers the safety of Intravenous MK-3475/Intravesical BCG to be a 1 due to this being an early stage trial, with limited evidence regarding efficacy and safety."

Answered by AI

For what medical condition is the combination of MK-3475 and BCG administered intravenously or intravesically?

"The dual-agent treatment of Intravenous MK-3475 coupled with Intravesical BCG can be used to treat malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Recent research and studies

BMJ OpenJournal

Protocol for Phase I Study of Pembrolizumab in Combination with Bacillus Calmette-guérin for Patients with High-risk Non-muscle Invasive Bladder Cancer

Jamil, Marcus L, Mustafa Deebajah, Akshay Sood, Kathy Robinson, Krishna Rao, Sherjeel Sana, and Shaheen Alanee. 2019. “Protocol for Phase I Study of Pembrolizumab in Combination with Bacillus Calmette-guérin for Patients with High-risk Non-muscle Invasive Bladder Cancer”. BMJ Open. BMJ. doi:10.1136/bmjopen-2018-028287.

clinicaltrials.govStudy

MK-3475/BCG in High Risk Superficial Bladder Cancer

2015. "MK-3475/BCG in High Risk Superficial Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02324582.

All > Bladder Cancer