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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

Must not have

Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis

Squamous cell carcinoma of the skin or of salivary gland origin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had lung inflammation treated with steroids or have a lung condition.

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My cancer is squamous cell carcinoma of the skin or salivary gland.

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I do not have severe numbness or pain in my hands or feet.

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I am allergic to carboplatin, pembrolizumab, or paclitaxel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-month Progression-free Survival (PFS)

Secondary study objectives

Adverse Events (AE) and Serious Adverse Events (SAE) Related to Treatment

Duration of Response (DOR)

Overall Response Rate (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Paclitaxel

2011

Completed Phase 4

~5450

Pembrolizumab

2017

Completed Phase 3

~3150