30 Participants Needed

Pembrolizumab + Chemotherapy for Head and Neck Cancer

AR
Overseen ByAri Rosenberg, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a blood test measuring tumor DNA can guide the optimal use of chemotherapy and immunotherapy for people with head and neck cancer. Researchers seek to discover whether adding occasional chemotherapy to regular immunotherapy is more effective than using immunotherapy alone. The study seeks participants with head and neck cancer that has recurred or spread and who have not yet received certain treatments for their condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on investigational agents or certain immunosuppressive therapies, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pembrolizumab, a medication used in this study, is generally well-tolerated. In studies involving 192 patients with head and neck squamous cell carcinoma (HNSCC), most patients tolerated pembrolizumab well. However, like many treatments, it can cause side effects, which vary among individuals.

When combined with carboplatin and paclitaxel, research indicates that this combination is generally safe. While side effects can occur, they are usually not severe enough to outweigh the potential benefits. Many patients have continued treatment without major issues.

Overall, safety data suggest that both pembrolizumab alone and in combination with carboplatin and paclitaxel are generally well-tolerated, with most side effects being manageable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about pembrolizumab in combination with chemotherapy for head and neck cancer because this approach leverages the power of immunotherapy alongside traditional chemotherapy. Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively, which is different from standard chemotherapy treatments that directly target and kill rapidly dividing cells. This combination has the potential to enhance the effectiveness of treatment by not only attacking the cancer cells directly but also empowering the body's own immune system to fight back. Meanwhile, using pembrolizumab alone offers a treatment option that may reduce the need for traditional chemotherapy, potentially leading to fewer side effects while still harnessing the immune system's strength. These innovative approaches open up new possibilities for improved outcomes in patients with head and neck cancer.

What evidence suggests that this trial's treatments could be effective for head and neck cancer?

Research shows that pembrolizumab, when used alone, can benefit people with head and neck squamous cell carcinoma (HNSCC). Studies have found that pembrolizumab can extend survival compared to standard treatments. In this trial, some participants will receive pembrolizumab alone, while others will receive it combined with chemotherapy drugs like carboplatin and paclitaxel. This combination has shown promising results in fighting tumors and is often used as the first treatment for patients with recurrent or metastatic head and neck cancer. Overall, evidence suggests that pembrolizumab, both alone and with chemotherapy, can effectively treat head and neck cancer.16789

Who Is on the Research Team?

Ari Rosenberg, MD - UChicago Medicine

Ari Rosenberg, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My organ and bone marrow functions are normal.
I am fully active or restricted in physically strenuous activity but can do light work.
Have measurable disease based on RECIST 1.1 criteria
See 9 more

Exclusion Criteria

I have received an organ or tissue transplant from another person.
I have cancer that has spread to my brain.
I had radiation therapy less than 2 weeks ago or am still dealing with its side effects.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab with or without chemotherapy based on circulating tumor DNA response for two 21-day cycles

6 weeks
2 visits (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Extension

Participants may continue to receive treatment based on response and safety assessments

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Paclitaxel
  • Pembrolizumab
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and PaclitaxelExperimental Treatment3 Interventions
Group II: Group 1: Participants Who Receive Pembrolizumab (Alone)Experimental Treatment1 Intervention

Carboplatin is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Published Research Related to This Trial

In a small retrospective study of 10 patients with recurrent or metastatic squamous cell carcinoma of the head and neck, the combination of pembrolizumab with carboplatin and paclitaxel (pembro + CP) was well tolerated, with 100% of patients experiencing mild adverse events and 30% experiencing more severe side effects.
The overall response rate (ORR) was 14% with one complete response, and the disease control rate (DCR) was 43%, indicating that while the treatment showed some effectiveness, further prospective studies are needed to fully evaluate its safety and efficacy.
Safety and preliminary activity of pembrolizumab-carboplatin-paclitaxel in heavily pretreated and/or fragile patients with PDL1-positive recurrent/metastatic head and neck cancer.Cabezas-Camarero, S., Merino-Menéndez, S., Cabrera-Martín, MN., et al.[2023]
In a study of 38 patients with p16+ oropharyngeal squamous cell carcinoma, there was a 76% agreement in PD-L1 combined positive scores (CPS) between primary tumors and lymph node metastases, indicating variability in scoring between these specimens.
The interobserver agreement for CPS scoring was fair to substantial, suggesting that additional evaluations may be necessary to ensure accurate scoring, especially for patients who might benefit from immunotherapy.
Programmed Death Ligand-1 Combined Positive Score Concordance and Interrater Reliability in Primary Tumors and Synchronous Lymph Node Metastases in Resected Cases of p16+ Oropharyngeal Squamous Cell Carcinoma.Kaur, A., Kuchta, K., Watkin, W., et al.[2023]
In a phase IB study involving 59 patients with locally advanced head and neck squamous cell carcinoma, the combination of pembrolizumab with cisplatin-based chemoradiotherapy was found to be safe, with a high completion rate of treatment and only 8.8% of patients experiencing immune-related adverse events.
The treatment showed promising efficacy, with complete response rates of 85.3% for HPV-positive and 78.3% for HPV-negative patients, suggesting that this combination warrants further investigation.
Safety and Efficacy of Pembrolizumab With Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase IB Study.Powell, SF., Gold, KA., Gitau, MM., et al.[2022]

Citations

European Commission Approves KEYTRUDA® ...KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express ...
Real-World Evidence on the Effectiveness of Pembrolizumab ...The study showed some beneficial effects of pembrolizumab monotherapy in recurrent/metastatic/unresectable HNSCC patients in real-world scenarios.
Study Details | NCT02252042 | Pembrolizumab (MK-3475) ...The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment.
Neoadjuvant and Adjuvant Pembrolizumab in Locally ...The addition of neoadjuvant and adjuvant pembrolizumab to standard care significantly improved event-free survival among participants with locally advanced ...
KEYTRUDA used with chemotherapy as first treatmentHalf of the people who received KEYTRUDA and chemotherapy were alive without their cancer spreading, growing, or getting worse at 4.9 months, compared to 5.1 ...
pembrolizumab (KEYTRUDA)Safety data was evaluated in 192 patients with HNSCC receiving at least one dose of pembrolizumab 10 mg/kg every 2 weeks or 200 mg every 3 weeks ...
head and neck squamous cell cancer (HNSCC)Important Safety Information. KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system ...
Efficacy and safety of pembrolizumab in recurrent/metastatic ...These data demonstrate that a subset of patients will receive long-term benefit from treatment with pembrolizumab, a paradigm rarely observed ...
Study Details | NCT02252042 | Pembrolizumab (MK-3475) ...The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment. Official Title. A Phase III ...
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