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PD-L1 Inhibitor

Pembrolizumab for Adenoid Cystic Carcinoma

Phase 2
Waitlist Available
Led By Jonathan Schoenfeld, MD, MPH
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 2 years
Awards & highlights

Study Summary

This trial is studying how well immunotherapy with or without radiation therapy works in treating adenoid cystic carcinoma.

Eligible Conditions
  • Adenoid Cystic Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans)
Secondary outcome measures
Number of Participants With Complete Response (Absence of Non-irradiated Lesions on Scans)
Number of Participants With Partial Response (Tumor Size on Scans)
Number of Treatment-Emergent Adverse Events
+2 more

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: Pembrolizumab + RadiationExperimental Treatment2 Interventions
Up to 5 metastatic lesions targeted with radiation Over 5 fractions starting within 7 calendar days following the first dose of pembrolizumab Pembrolizumab will be administered on day 1 of each 21day cycle Pembrolizumab is delivered intravenously
Group II: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab will be administered on day 1 of each 21day cycle Pembrolizumab is delivered intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 3
~1020
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,062 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,965 Total Patients Enrolled
Jonathan Schoenfeld, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
21 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
International Journal of Radiation Oncology*Biology*PhysicsJournal
A Randomized Phase 2 Study of Pembrolizumab with or Without Radiation in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma
Mahmood, Umair, Andrew Bang, Yu-Hui Chen, Raymond H. Mak, Jochen H. Lorch, Glenn J. Hanna, Mizuki Nishino, et al.. 2021. “A Randomized Phase 2 Study of Pembrolizumab with or Without Radiation in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2020.08.018.
clinicaltrials.govStudy
Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
Jonathan Schoenfeld, MD, MPH 2017. "Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03087019.
~3 spots leftby Apr 2025
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