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PD-1 Inhibitor

Pembrolizumab for Kidney Cancer

Phase 1

Waitlist Available

Led By Roberto Pili, MD

Research Sponsored by Nabil Adra

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 18 months

Awards & highlights

Study Summary

This trial is testing a combination of two drugs, pembrolizumab and vorinostat, to treat advanced prostate, renal, or urothelial cell carcinoma. The primary objective is to assess the early signals for anti-tumor activity, and the secondary objectives are to evaluate the overall safety profile, select the recommended Phase 2 Dose, and characterize immune cell subsets and miRs in tumor and/or blood.

Eligible Conditions

Kidney Cancer
Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective response rate

Progression free survival

Secondary outcome measures

Find Recommended Phase 2 Dose (RP2D) of pembrolizumab in combination with vorinostat

Serious adverse events, adverse events (AEs) and discontinuations due to AEs will be summarized according to CTCAE 4.0

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion CohortExperimental Treatment2 Interventions

Once the Expansion Test Dose is identified, the Dose Expansion Phase will be opened and the combination will be tested in patients with advanced renal cell or urothelial cell carcinoma. Forty-five patients with prior treatments will be enrolled in three expansion cohorts: 15 anti-PD1 naive renal and urothelial patients, 15 anti-PD1 resistant renal and urothelial patients (defined as patients with transient clinical response or without clinical response to prior immune-checkpoint inhibition), and 15 patients with androgen-sensitive or castration-resistant prostate cancer.

Group II: Dose Finding CohortExperimental Treatment2 Interventions

Estimate the Recommended Phase 2 Dose (RP2D) in patients with advanced renal and urothelial cell carcinoma patients. Patients will be treated with oral vorinostat every day for 14 days, and with pembrolizumab at the fixed dose of 200 mg IV. Each cycle is every 21 days. Two dose levels of vorinostat will be tested in 2 patient cohorts according to the 3 + 3 standard design (100 and 200 mg).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Vorinostat

2014

Completed Phase 3

~1600

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nabil AdraLead Sponsor

4 Previous Clinical Trials

138 Total Patients Enrolled

Roberto Pili, MDPrincipal InvestigatorIndiana University School of Medicine, Indiana University Simon Cancer Center

5 Previous Clinical Trials

353 Total Patients Enrolled

Frequently Asked Questions

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

Is this investigation currently accepting participants?

"As per information on clinicaltrials.gov, this research is not presently recruiting new patients; the trial was first posted in January 14th 2016 and updated most recently on April 19th 2022. Notwithstanding, other trials are actively searching for participants with 3805 studies currently listed as open to enrollment."

Answered by AI

How many participants are included in the current clinical trial?

"As of April 19th 2022, this trial has closed to new candidates. The study was first made available on January 14th 2016 and is no longer accepting applicants. However, there are currently 2819 clinical trials recruiting patients with urinary bladder cancer and 986 medical studies searching for participants treated with Pembrolizumab."

Answered by AI

Are there precedents to the current clinical examination into Pembrolizumab?

"Pembrolizumab was initially researched at the National Cancer Institute Neuro-Oncology Branch in 2005, and has since seen 392 completed trials. Presently, there are 986 medical studies utilizing this drug actively recruiting with a great number of these inquiries taking place in Baltimore, Maryland."

Answered by AI

Has the FDA accorded authorization for Pembrolizumab?

"The safety of Pembrolizumab was assessed as a 1, given that this is only in its first testing phase and there is limited data regarding its efficacy."

Answered by AI

What therapeutic applications is Pembrolizumab typically employed for?

"Pembrolizumab is commonly used to treat malignant neoplasms, and it has also been applied in the treatment of certain cases of unresectable melanoma, microsatellite instability high, and progressive cutaneous t-cell lymphoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma

Nabil Adra 2016. "Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02619253.