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Alkylating agents
Chemotherapy + Pembrolizumab for Head and Neck Cancer
Phase 2
Recruiting
Led By Dan P Zandberg, MD
Research Sponsored by Dan Zandberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent/metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies
Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial proposes a new chemo sequence to maximize effectiveness of anti-PD-1 mAb therapy. It suggests chemo after mAb, not before, may be more effective.
Who is the study for?
Adults with recurrent or metastatic head and neck squamous cell carcinoma, not curable by local therapies. Participants must have a certain level of platelets, normal organ/marrow function, no severe allergies to trial drugs, and no recent immunotherapy or chemotherapy for this condition. They should be in relatively good health (ECOG PS 0-2) and willing to use contraception.Check my eligibility
What is being tested?
The trial is testing a new way of giving chemotherapy in short bursts (pulsed dose) plus Pembrolizumab. The idea is that standard chemo might weaken the immune system too much when given with Pembrolizumab, an anti-PD-1 mAb therapy. This study will see if pulsed chemo works better after the mAb treatment.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used (Pembrolizumab, Carboplatin, Paclitaxel), blood disorders from low platelet/neutrophil counts, liver/kidney function issues due to drug toxicity, fatigue from treatment burden and potential nerve damage leading to sensory neuropathy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.
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I can take care of myself and perform daily activities.
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I am older than 18 years.
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My kidney function is adequate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month Progression-free Survival (PFS)
Secondary outcome measures
Adverse Events (AE) and Serious Adverse Events (SAE) Related to Treatment
Duration of Response (DOR)
Overall Response Rate (ORR)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + Carboplatin with PaclitaxelExperimental Treatment3 Interventions
Pembrolizumab: Administer 200 mg intravenously (IV) every 3 weeks (q3w); maintenance will be continued at 400 mg IV q6w for 12 cycles for a total of 2 years of therapy
Carboplatin: Started with cycle 2 (C2) of pembrolizumab and continued thereafter every 3rd cycle of pembrolizumab for a total of 4 cycles with paclitaxel; carboplatin will be given at C2, C5, C8, and C11 of pembrolizumab.
Paclitaxel: Started with cycle 2 (C2) of pembrolizumab and continued thereafter every 3rd cycle of pembrolizumab for a total of 4 cycles with carboplatin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Dan ZandbergLead Sponsor
5 Previous Clinical Trials
273 Total Patients Enrolled
Dan P Zandberg, MDPrincipal InvestigatorUPMC Hillman Cancer Center
3 Previous Clinical Trials
76 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment begun for this trial?
"An examination of the information presented on clinicaltrials.gov shows that this trial is no longer accepting participants; it was first posted in September 1st 2023 and last modified on 18th of the same month. However, there are 1,493 other medical studies currently recruiting patients."
Answered by AI
Has the combination of Pembrolizumab, Carboplatin and Paclitaxel been recognized by the Food & Drug Administration?
"At Power, we rated the safety of Pembrolizumab + Carboplatin with Paclitaxel a 2 due to its Phase 2 status. This means that there is prior clinical evidence supporting safety but not efficacy yet."
Answered by AI
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