Head and Neck CancerPhase 2NCT05420948
A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer
A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Neoplasms
- What is being tested?
- Pembrolizumab, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in study.
- Has received prior therapy with an anti-PD1(anti-programmed cell death protein1) therapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Pregnant women are excluded from this study because pembrolizumab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding should be discontinued if the mother is treated with pembrolizumab. These potential risks may also apply to other agents used in this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pembrolizumab, carboplatin, and paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Has known active Hepatitis B or Hepatitis C. However, if eradicated participant is eligible.
- Has a history of active infection requiring systemic therapy.
- Has received a live vaccine within 28 days of planned start of study therapy. Note: Vaccines for COVID-19 are allowed except for any live vaccine that may be developed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Cancer Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ari Rosenberg
About this study
Official title: A Phase II Study of Pembrolizumab in Combination With Circulating Tumor DNA Response-Adaptive Pulsed Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: The SINERGY Trial (Squamous Cell Carcinoma of Head and Neck Response-Guided Therapy)
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.
Read the detailed description
By doing this study, the research team hopes 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.
The purpose of this research is to gather information on how well immunotherapy with intermittent chemotherapy guided by measurements of tumor DNA in blood will work and to learn about the safety and effectiveness of this new treatment strategy. All of the drugs used in this trial are approved by the US Food and Drug Administration (FDA); however, they are being combined in a new way based on changes in tumor DNA in the participant's blood which can only be done in a research study.
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Neoplasms, Head Cancer, Throat Carcinoma
- Being tested
- Pembrolizumab, Carboplatin, Paclitaxel
- Keywords
- head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called KEYTRUDA
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.
CarboplatinDrug
Also called Paraplatin
A chemotherapy drug used to treat cancer.
PaclitaxelDrug
Also called Taxol
A chemotherapy drug used to treat cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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.. Receives: 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. Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The rate of adverse events (Grade 3 of higher) reported among participants who receive pembrolizumab + chemotherapy compared to the rate of adverse events (Grade 3 or higher) reported among participants who received pembrolizumab +chemotherapy in a previous related study called Keynote-48. Adverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Measured: 2 years
Progression Free Survival of Participants Receiving Pembrolizumab + Chemotherapy
Progression Free Survival of pembrolizumab combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy among participants. Progression free survival will be defined as the time from date of first dose of study drug to date of documented progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors version 1.1 ( RECIST v1.1 )or death, whichever occurs first.
Measured: 2 years
Overall Survival of Participants Receiving Pembrolizumab + Chemotherapy
The overall survival of pembrolizumab in combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy in participants with head and neck cancer. Overall survival will be defined as the time from the date of first dose of study drug to the date of death.
Measured: 2 years
Duration of Response of Participants Receiving Pembrolizumab + Chemotherapy
The duration of response (DoR) of pembrolizumab in combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy in participants with head and neck cancer. Duration of response will be defined as the time from date of first documented response to the date of documented progressive disease or death, based on Response Evaluation Criteria in Solid Tumors version 1.1 ( RECIST v1.1).
Measured: 2 years
The Rate of Adverse Events Reported Among Study Participants Receiving Pembrolizumab + Chemotherapy
The rate of adverse events reported among participants who receive pembrolizumab in combination with chemotherapy as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Measured: 2 years
Rate of Adverse Events Leading to Discontinuation or Death Among Participants
Rate of adverse events leading to discontinuation or death among participants as assessed by Common Criteria Terminology for Adverse Events (CTCAE v. 5.0).
Measured: 2 years
Proportion of Participants who Receive a Lower Dose of Study Drugs After Treatment with Pembrolizumab + Chemotherapy
Proportion of participants who begin to receive a lower dose of study drugs (known as a "de-escalated" dose) based on decreases in circulating tumor DNA (ctDNA) from pembrolizumab and chemotherapy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start17 Oct 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ari Rosenberg, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420948
- Sponsor's protocol ID
- IRB22-0288
- Status last verified
- May 2026
- First submitted
- 13 Jun 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pembrolizumab in Combination With Circulating Tumor DNA Response-Adaptive Pulsed Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: The SINERGY Trial (Squamous Cell Carcinoma of Head and Neck Response-Guided Therapy)
- ClinicalTrials.gov ID
- NCT05420948
- Acronym / sponsor ID
- IRB22-0288
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Neoplasms, Head Cancer, Throat Carcinoma
- Keywords
- head and neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
By doing this study, the research team hopes 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.
The purpose of this research is to gather information on how well immunotherapy with intermittent chemotherapy guided by measurements of tumor DNA in blood will work and to learn about the safety and effectiveness of this new treatment strategy. All of the drugs used in this trial are approved by the US Food and Drug Administration (FDA); however, they are being combined in a new way based on changes in tumor DNA in the participant's blood which can only be done in a research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Participants Who Receive Pembrolizumab (Alone) | Experimental | Drug: PembrolizumabParticipants 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.. |
| Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel | Experimental | Drug: Pembrolizumab, Drug: Carboplatin, Drug: PaclitaxelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KEYTRUDAA 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. | Drug | Group 1: Participants Who Receive Pembrolizumab (Alone), Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel |
| CarboplatinAlso: ParaplatinA chemotherapy drug used to treat cancer. | Drug | Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel |
| PaclitaxelAlso: TaxolA chemotherapy drug used to treat cancer. | Drug | Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel |
Primary outcome
Objective Response Rate of Participants as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: 2 years
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).
7 secondary outcomes
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
Time frame: 2 years
Progression Free Survival of Participants Receiving Pembrolizumab + Chemotherapy
Time frame: 2 years
Overall Survival of Participants Receiving Pembrolizumab + Chemotherapy
Time frame: 2 years
Duration of Response of Participants Receiving Pembrolizumab + Chemotherapy
Time frame: 2 years
The Rate of Adverse Events Reported Among Study Participants Receiving Pembrolizumab + Chemotherapy
Time frame: 2 years
Rate of Adverse Events Leading to Discontinuation or Death Among Participants
Time frame: 2 years
Proportion of Participants who Receive a Lower Dose of Study Drugs After Treatment with Pembrolizumab + Chemotherapy
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ari Rosenberg, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ari Rosenberg, MD (773-834-3398, arirosenberg@medicine.bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate of Participants as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.