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PD-1 Inhibitor

Pembrolizumab for Anal Cancer

Phase 2

Waitlist Available

Led By James Cleary, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

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 disease was evaluated radiologically at baseline and every 3 cycles on treatment. the median follow-up was 12.6 months. all registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)

Awards & highlights

Study Summary

This trial is studying how well pembrolizumab works in treating patients with anal cancer.

Eligible Conditions

Anal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease was evaluated radiologically at baseline and every 3 cycles on treatment. the median follow-up was 12.6 months. all registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~disease was evaluated radiologically at baseline and every 3 cycles on treatment. the median follow-up was 12.6 months. all registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease was evaluated radiologically at baseline and every 3 cycles on treatment. the median follow-up was 12.6 months. all registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 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

Overall Response Rate

Secondary outcome measures

Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab

Overall Survival

PD-L1 Positive Response Rate

+1 more

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

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

Pembrolizumab is administered every 3 week intravenously Dosage to be determine by physician

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,055,019 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,910 Total Patients Enrolled

James Cleary, MD, PhD5.02 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute

Dana-Farber Cancer Institute

4 Previous Clinical Trials

106 Total Patients Enrolled

5Patient Review

Dr. Smith is very caring and compassionate. He likes to get to know his patients and their journey.

Frequently Asked Questions

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

What other explorations of Pembrolizumab have occurred?

"Currently, 961 Pembrolizumab trials are underway with 122 of them in phase 3. Houston stands as the major centre for these studies; however, there are 35728 locations across the globe conducting research on this drug."

Answered by AI

Is enrollment for this experiment accessible to participants now?

"Data from clinicaltrials.gov reveals that this study, which was initially posted on October 11th 2016, is not currently recruiting patients anymore. However, the website has 1024 other medical trials presently open for enrolment."

Answered by AI

What is the participant cap for this scientific research?

"Recruitment for this trial has closed. The research was initially posted on October 11th, 2016 and last updated April 27th 2022. Alternatives are available; as of now there 63 trials recruiting for participants with cancer, anorexia nervosa, and 961 studies actively seeking patients to take part in pembrolizumab treatments."

Answered by AI

Has the FDA granted clearance for Pembrolizumab?

"Clinical data suggests a degree of safety for Pembrolizumab, leading to our team at Power assigning it an evaluation score of 2. This is because the drug has been tested before in Phase 2 trials but not with regards to efficacy."

Answered by AI

To what ailments is Pembrolizumab most commonly prescribed?

"Pembrolizumab is a common remedy for malignant neoplasms and has been used to help treat unresectable melanoma, microsatellite instability high, and diseases that have progressed after chemotherapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab in Metastatic Anal Cancer

James Cleary, MD, PhD 2016. "Pembrolizumab in Metastatic Anal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02919969.