← Back to Search

Alkylating agents

Pembrolizumab + Chemotherapy for Head and Neck Cancer

Phase 2

Recruiting

Led By Ari Rosenberg, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have normal organ and marrow function as defined by clinical lab values

Eastern Cooperative Oncology Group performance status of 0 or 1

Must not have

Has had an allogeneic tissue/solid organ transplant

Known brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial aims to find out if a blood test can predict who will respond best to chemo + immunotherapy for head and neck cancer. It will last two years.

Who is the study for?

Adults with confirmed recurrent or metastatic head and neck cancer, who haven't had systemic therapy for this setting, can join. They must have a performance status of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but can do light work), measurable disease, normal organ/marrow function, and provide tissue for PD-L1 analysis. Women must not be pregnant/breastfeeding and agree to contraception; men with partners capable of pregnancy must also use contraception.

What is being tested?

The trial is testing Pembrolizumab combined with chemotherapy drugs Carboplatin and Paclitaxel in patients with head and neck cancer. It aims to see if using a blood test to measure tumor DNA helps guide the intermittent addition of chemotherapy to immunotherapy compared to just immunotherapy alone over about two years.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects like inflammation in organs, skin reactions, hormone gland problems (like thyroid issues), infusion reactions, fatigue, appetite changes, nausea. Chemotherapy drugs like Carboplatin and Paclitaxel can cause hair loss (alopecia), nerve damage (neuropathy), low blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My organ and bone marrow functions are normal.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I have provided a tissue sample for PD-L1 analysis.

Select...

I am 18 years old or older.

Select...

My head or neck cancer has come back or spread.

Exclusion Criteria

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

Select...

I have received an organ or tissue transplant from another person.

Select...

I have cancer that has spread to my brain.

Select...

I had radiation therapy less than 2 weeks ago or am still dealing with its side effects.

Select...

I have had or currently have lung inflammation treated with steroids.

Select...

My condition can be treated with the goal of curing it.

Select...

I am HIV-positive and on combination antiretroviral therapy.

Select...

I have an active Hepatitis B or C infection.

Select...

I have had an infection that needed treatment with medication.

Select...

I do not have any unmanaged ongoing illnesses.

Select...

I have been treated with anti-PD1 therapy before.

Select...

My doctor expects I have less than 3 months to live or my disease is getting worse quickly.

Select...

I have an active cancer that is not a non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

Primary study objectives

Objective Response Rate of Participants as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Secondary study objectives

Duration of Response of Participants Receiving Pembrolizumab + Chemotherapy

Overall Survival of Participants Receiving Pembrolizumab + Chemotherapy

Progression Free Survival of Participants Receiving Pembrolizumab + Chemotherapy

+4 more

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and PaclitaxelExperimental Treatment3 Interventions

Participants in this group will receive 200 mg of pembrolizumab through an intravenous (IV) needle inserted into the arm plus chemotherapy with carboplatin (AUC 6) on day 1 and paclitaxel (200 mg) on day 1 of each 21-day cycle for two cycles.

Group II: Group 1: Participants Who Receive Pembrolizumab (Alone)Experimental Treatment1 Intervention

Participants in this group will receive pembrolizumab 200 mg through an intravenous (IV) needle inserted into the arm. Medications will be given on day 1 of each 21-day cycle for two cycles..

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Carboplatin

FDA approved

Paclitaxel

FDA approved

0 / 17Eligibility criteria met