A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer

NCT05420948 | Suspended Phase 2 FDA Drug

• 1 other identifier: IRB22-0288
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.

Conditions

Head and Neck Squamous Cell Carcinoma; Head and Neck Neoplasms; Head Cancer; Throat Carcinoma; Head and Neck Cancer

Keywords

head and neck cancer

Outcome Measures

Primary Outcomes (1)

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

  Overall response rate with pembrolizumab in combination with circulating tumor DNA (ctDNA) chemotherapy among subjects with head and neck cancer. Response rate will be defined as the proportion of participants with a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

  2 years

Secondary Outcomes (7)

• The Rate of Adverse Events Reported Among Study Participants Receiving Pembrolizumab + Chemotherapy Compared to The Rate of Adverse Events Reported Among Participants Who Received Pembrolizumab + Chemotherapy in a Related Study

  2 years

• Progression Free Survival of Participants Receiving Pembrolizumab + Chemotherapy

  2 years

• Overall Survival of Participants Receiving Pembrolizumab + Chemotherapy

  2 years

• Duration of Response of Participants Receiving Pembrolizumab + Chemotherapy

  2 years

• The Rate of Adverse Events Reported Among Study Participants Receiving Pembrolizumab + Chemotherapy

  2 years

Study Arms (2)

Group 1: Participants Who Receive Pembrolizumab (Alone)

EXPERIMENTAL

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..

Drug: Pembrolizumab

Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel

EXPERIMENTAL

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.

Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Pembrolizumab DRUG

A drug that binds to a protein called programmed cell death 1 (PD-1) to help immune cells kill cancer cells better. Pembrolizumab is used to treat many different types of cancer.

Also known as: KEYTRUDA

Group 1: Participants Who Receive Pembrolizumab (Alone); Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel

Carboplatin DRUG

A chemotherapy drug used to treat cancer.

Also known as: Paraplatin

Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel

Paclitaxel DRUG

A chemotherapy drug used to treat cancer.

Also known as: Taxol

Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have clinically confirmed head and neck cancer that is recurrent (comes back/returns to the body) or metastatic (spreads to other parts of the body).
• Participants should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 3 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.
• Greater than or equal to 18 years old.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Have measurable disease based on RECIST 1.1 as determined by the site. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Participants must have normal organ and marrow function as defined by clinical lab values.
• Participants must have provided tissue for programmed cell death ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate). Repeat samples may be required if adequate tissue is not provided. A newly obtained biopsy (within 90 days prior to start of study treatment) is strongly preferred, but an archival sample is acceptable.
• Measurable disease (either primary site and/or nodal disease) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• Participants must sign a study-specific informed consent form prior to study entry. Participants should have the ability to understand and the willingness to sign a written informed consent document.
• Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
• Women must not be breastfeeding.
• Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.
• Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).

You may not qualify if:

• Has disease that is suitable for local therapy administered with curative intent.
• Has progressive disease (PD) within three (3) months of completion of curatively intended systemic treatment for locoregionally advanced head and neck cancer.
• Participants who are receiving any other investigational agents.
• Participants in whom signatera ctDNA is not measurable at baseline.
• Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment or patient has not fully recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered treatment.
• Note: Participants with ≤Grade 2 neuropathy, ≤Grade 2 alopecia, are an exception to this criterion and may qualify for the study.
• Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Active, known, or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy, with the exception of low-dose prednisone (\<= 10mg or equivalent). The following are exceptions to these criteria:
• Participants with vitiligo or alopecia.
• Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
• Any chronic skin condition that does not require systemic treatment.
• Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.
• Participants with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Has had an allogeneic tissue/solid organ transplant.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Ari Rosenberg, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 15, 2022
• Study Start: October 17, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)