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Pembrolizumab + Olaparib for Head and Neck Cancer
Phase 2
Recruiting
Led By Siddharth Sheth, DO MPH
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy confirmed American Joint Committee on Cancer 8th Edition stage III-IV B oral cavity squamous cell carcinoma (SCC), p16-negative oropharyngeal SCC, stage III-IVB hypopharyngeal SCC, stage III-IVB laryngeal SCC -OR- HPV-associated oropharyngeal SCC (p16 positive or HPV-associated) T4 or N3, T1-3 N2 or T3N0-1 with >10 pack-year tobacco history
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from start of treatment
Awards & highlights
Study Summary
This trial will test whether using pembrolizumab and olaparib together before and after chemoradiation therapy is more effective in treating locally advanced head and neck squamous cell carcinoma than chemoradiation therapy alone.
Who is the study for?
This trial is for adults over 18 with certain types of head and neck squamous cell carcinoma (HNSCC) that haven't been treated yet. Participants need to be in good physical condition, able to follow the study plan, and have a tumor assessable by imaging. They can't join if they've had other cancer treatments recently, can't swallow pills, are ineligible for cisplatin therapy, or have severe medical issues.Check my eligibility
What is being tested?
The trial tests pembrolizumab plus olaparib before and after standard chemoradiation therapy for advanced HNSCC. These drugs are approved separately but not together; this study examines their combined effectiveness when paired with chemo and radiation.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects like inflammation in organs or skin reactions. Olaparib could lead to blood cell count changes, nausea, fatigue or respiratory issues. Cisplatin might result in kidney problems, hearing loss or nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced stage mouth or throat cancer, not caused by HPV unless I have a heavy smoking history.
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I am fully active or can carry out light work.
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I have at least one cancer lesion that can be monitored through scans.
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I haven't had treatments aimed at curing my cancer and haven't been in a drug/device trial recently.
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I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
One Year Progression Free Survival (PFS)
Secondary outcome measures
Correlate Combined Positive Score (CPS) and one-year progression free survival (PFS)
Distant Metastasis-Free Survival (DMFS)
General Cancer Associated Patient Reported Outcomes (PRO)
+8 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment4 Interventions
The participants will receive neoadjuvant and adjuvant pembrolizumab and olaparib combination plus standard of care (chemoradiation therapy) as defined in the protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2210
Cisplatin
2013
Completed Phase 3
~1940
IMRT (intensity modulated radiation therapy)
2014
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
353 Previous Clinical Trials
90,367 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,901 Previous Clinical Trials
5,062,914 Total Patients Enrolled
Siddharth Sheth, DO MPHPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have advanced stage mouth or throat cancer, not caused by HPV unless I have a heavy smoking history.I am fully active or can carry out light work.I cannot swallow pills before starting the study treatment.I have at least one cancer lesion that can be monitored through scans.I haven't had treatments aimed at curing my cancer and haven't been in a drug/device trial recently.I am taking steroids only for immune-related symptoms, not for other reasons.I have had cancer before, but it won't affect this study's treatment, except for head and neck cancer treated within the last 3 years.I do not have any severe, uncontrolled health issues.I am over 18 years old.I cannot receive cisplatin as per my treatment plan.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the cohort involved in this investigation?
"Affirmative. According to the information maintained by clinicaltrials.gov, this medical trial is actively recruiting participants since it was initially posted on September 2nd 2022 and updated lastly on October 25th of that same year. 45 patients need to be sourced from two different hospital locations."
Answered by AI
Has the FDA granted its seal of approval to Pembrolizumab?
"With some data to back up its safety, Pembrolizumab was given a score of 2 since this is only Phase 2 trial and there are no results confirming its efficacy."
Answered by AI
Is it currently possible for individuals to join this experiment?
"The information published on clinicaltrials.gov reveals that this medical trial is presently seeking willing participants. This investigation was initially announced on September 2nd 2022, and the most recent update occured on October 25th of the same year."
Answered by AI
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