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PD-L1 Inhibitor

Pembrolizumab for Neuroendocrine Carcinoma

Phase 2
Waitlist Available
Led By Emily Bergsland, MD
Research Sponsored by University of California, San Francisco
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 approximately 2 years
Awards & highlights

Study Summary

This trial is testing a new treatment for a type of cancer that starts outside of the lungs and is hard to treat.

Eligible Conditions
  • Neuroendocrine Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 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
Overall Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Overall Survival (OS)
Progression Free Survival (PFS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Pembrolizumab + ChemotherapyExperimental Treatment3 Interventions
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion
Group II: Part A: Pembrolizumab onlyExperimental Treatment1 Intervention
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Irinotecan
2017
Completed Phase 4
~2680
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,519 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,110 Total Patients Enrolled
Emily Bergsland, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
329 Total Patients Enrolled

Frequently Asked Questions

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

Can you elucidate the safety profile of Pembrolizumab for humans?

"Given its Phase 2 status, evidence of safety but lack of efficacy data led us to assign Pembrolizumab a score of 2 on our scale."

Answered by AI

Is enrollment in this research project currently available to volunteers?

"The clinicaltrials.gov database indicates that this medical trial is not actively enrolling patients as of now; the first posting was on August 10th 2017, and it has been updated most recently on August 8th 2022. Nonetheless, there are 4420 other trials currently recruiting participants."

Answered by AI

What other research initiatives have been undertaken using Pembrolizumab?

"Currently, 1919 medical studies exploring the use of Pembrolizumab are currently in progress. 369 of these underway trials are at Phase 3 and span 81678 distinct locations predominantly situated within Shanghai."

Answered by AI

How many participants are there in this experiment?

"At this time, no further candidates are being sought for this clinical trial. Initially posted on August 10th, 2017 and last updated 8/8/2022, the study is closed to new participants. If you're looking into other trials related to carcinoma or Pembrolizumab there are 2501 and 1919 studies respectively that currently recruiting patients."

Answered by AI

What therapeutic effects have been observed when utilizing Pembrolizumab?

"Pembrolizumab is frequently used to treat malignant neoplasms, however it can also be utilised to curb the progression of unresectable melanoma, colorectal carcinoma and microsatellite instability high."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
2017. "Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03136055.
~5 spots leftby Apr 2025
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