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Pembrolizumab (MK-3475) for Bladder Cancer

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, NY
Bladder CancerPembrolizumab (MK-3475) - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing whether combining the immunotherapy drug pembrolizumab with the standard treatment of BCG will be more effective than BCG alone in treating bladder cancer.

Eligible Conditions
  • Bladder Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
SRK-181
1
Durvalumab
1
TU2218

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 6 months

6 months
The proportion of patients who are disease-free
The proportion of patients who remain free from high-grade recurrence

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
SRK-181
1
Durvalumab
1
TU2218

Side Effects for

1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
100%Lymphocyte count decreased
82%Alanine aminotransferase increased
82%Aspartate aminotransferase increased
82%Peripheral sensory neuropathy
82%Platelet count decreased
73%Anemia
73%White blood cell decreased
73%Hypoalbuminemia
64%Alkaline phosphatase increased
55%Diarrhea
55%Abdominal pain
55%Hypophosphatemia
55%Hyperglycemia
55%Blood bilirubin increased
55%Dysesthesia
55%Fatigue
45%Chills
45%Dehydration
45%Fever
45%Ascites
45%Serum amylase increased
45%Nausea
45%Hyponatremia
45%Neutrophil count decreased
45%Activated partial thromboplastin time prolonged
36%Paresthesia
36%Pain
36%Anorexia
36%Creatinine increased
36%Hypomagnesemia
36%Hypokalemia
36%Pruritus
36%Vomiting
27%Cough
27%Constipation
27%Dry mouth
27%Hypernatremia
27%Palmar-plantar erythrodysesthesia syndrome
18%Dizziness
18%Edema limbs
18%Anxiety
18%Rash maculo-papular
18%Dyspnea
18%Hypocalcemia
18%Sinus tachycardia
18%Weight loss
18%Depression
18%Colitis
18%Autoimmune disorder
18%Hypercalcemia
9%Lipase increased
9%Skin and subcutaneous tissue disorders - Other, Thrush- mouth
9%Skin and subcutaneous tissue disorders - Other, brittle nails
9%Skin and subcutaneous tissue disorders - Other, Erythema, swelling under bilat. Eyes
9%Skin and subcutaneous tissue disorders - Other, night sweats
9%Oral dysesthesia
9%Oral pain
9%Urinary tract infection
9%Abdominal distension
9%Flu like symptoms
9%Hemorrhoids
9%Immune system disorders - Other, Adrenal insufficiency
9%Infections and infestations - Other, Herpes labialis
9%Infections and infestations - Other, Erythema, swelling under bilat. Eyes
9%Insomnia
9%Bloating
9%Infections and infestations - Other, unknown origin
9%Back pain
9%Eye disorders - Other, Conjunctival hemorrhage
9%Epistaxis
9%Hyperuricemia
9%Gastrointestinal disorders - Other, indigestion
9%Headache
9%Gastritis
9%Mucositis oral
9%Gastrointestinal disorders - Other, Cramping
9%Hypermagnesemia
9%Malaise
9%Infections and infestations - Other, Mucositis
9%Skin and subcutaneous tissue disorders - Other, buttocks
9%Nasal congestion
9%Pleural effusion
9%Portal vein thrombosis
9%Urinary retention
9%Skin and subcutaneous tissue disorders - Other, Rash, nose
9%Skin and subcutaneous tissue disorders - Other, Skin lesion- cyst
9%Sore throat
9%Blurred vision
9%Skin and subcutaneous tissue disorders - Other, Swelling- lower leg
9%Skin and subcutaneous tissue disorders - Other, swelling - left foot
9%Non-cardiac chest pain
9%Dry eye
9%Fall
9%Infections and infestations - Other, Thrush - tongue, mucosal infection
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03111732) in the 1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine ARM group. Side effects include: Lymphocyte count decreased with 100%, Alanine aminotransferase increased with 82%, Aspartate aminotransferase increased with 82%, Peripheral sensory neuropathy with 82%, Platelet count decreased with 82%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4 Treatment Groups

Pembrolizumab (MK-3475) in combination with Bacillus Calmette-Guérin (BCG)
1 of 4
High Risk T1 Bladder Cancer Cohort
1 of 4
Exploratory cohort for high-grade non-muscle-invasive upper tract urothelial car...
1 of 4
Pembrolizumab (MK-3475)
1 of 4

Experimental Treatment

37 Total Participants · 4 Treatment Groups

Primary Treatment: Pembrolizumab (MK-3475) · No Placebo Group · Phase 2

Pembrolizumab (MK-3475) in combination with Bacillus Calmette-Guérin (BCG)Experimental Group · 2 Interventions: Pembrolizumab (MK-3475), Bacillus Calmette-Guérin (BCG) · Intervention Types: Drug, Drug
High Risk T1 Bladder Cancer CohortExperimental Group · 2 Interventions: Pembrolizumab (MK-3475), Bacillus Calmette-Guérin (BCG) · Intervention Types: Drug, Drug
Exploratory cohort for high-grade non-muscle-invasive upper tract urothelial carcinomaExperimental Group · 2 Interventions: Pembrolizumab (MK-3475), Bacillus Calmette-Guérin (BCG) · Intervention Types: Drug, Drug
Pembrolizumab (MK-3475)
Drug
Experimental Group · 1 Intervention: Pembrolizumab (MK-3475) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Bacillus Calmette-Guérin (BCG)
2014
Completed Phase 2
~1070

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,734 Previous Clinical Trials
4,973,417 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,862 Previous Clinical Trials
591,516 Total Patients Enrolled
Dean Bajorin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
3,445 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

How widespread is the implementation of this experiment?

"Patients may be recruited from 8 different sites, including Memorial Sloan Kettering West Harrison (All Protocol Activities), located in New York City's borough of Queens; Montvale’s Memorial Sloan Kettering Bergen (All protocol activities); and the renowned Memorial Sloan Kettering Cancer Center (All Protocol Activities) in Manhattan. Additionally, there are 5 other trial locations available." - Anonymous Online Contributor

Unverified Answer

Has Pembrolizumab (MK-3475) received governmental authorization?

"Due to the Phase 2 nature of this trial, Power's analysis concluded that Pembrolizumab (MK-3475) has a safety score of 2 as there is some evidence indicating its security but none attesting to its therapeutic effectiveness." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this clinical trial currently open?

"According to the data on clinicaltrials.gov, this medical experiment is currently recruiting trial participants. The original posting date was June 27th 2018 and it has been recently revised as of July 13th 2022." - Anonymous Online Contributor

Unverified Answer

What illnesses has Pembrolizumab (MK-3475) been utilized to combat?

"Pembrolizumab (MK-3475) is a popular choice for patients with malignant neoplasms. Additionally, this drug can be useful in treating unresectable melanoma, microsatellite instability high conditions, and cases where chemotherapy has been unsuccessful at halting disease progression." - Anonymous Online Contributor

Unverified Answer

What is the cumulative enrollment tally for this experiment?

"Affirmative. According to the records available on clinicaltrials.gov, this medical trial has been actively searching for participants since June 27th 2018 and was last updated July 13th 2022. Currently, 37 patients must be sourced from 8 healthcare centres." - Anonymous Online Contributor

Unverified Answer

Could you elucidate on any prior research conducted pertaining to Pembrolizumab (MK-3475)?

"Currently, 961 trials are underway to assess the efficacy of Pembrolizumab (MK-3475). Of these studies, 122 are in Phase 3. Although Houston, Texas is home to the bulk of those investigations, there exist 35727 locations across the globe conducting research on this drug." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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