PDT for Head and Neck Cancer

Not yet recruiting at 1 trial location

Overseen By Thomas Roberts, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: CYP450 inhibitors/inducers

Disqualifiers: EBV-associated carcinoma, Metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of three drugs—toripalimab (an immunotherapy), cisplatin, and docetaxel—to determine their safety and tolerability in treating advanced head and neck cancer, specifically squamous cell carcinoma. The researchers aim to discover if this treatment benefits individuals with locally advanced cancer that hasn't spread extensively. Suitable candidates include those newly diagnosed with specific types of head and neck cancer not caused by HPV, or certain cancer stages if HPV is involved. Participants should also have significant symptoms or a rapidly progressing tumor. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you must stop taking your current medications, but you cannot take medications that affect certain liver enzymes (CYP450). It's important to discuss your current medications with the trial team to ensure there are no interactions.

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

A previous study found that combining toripalimab with cisplatin and docetaxel caused some side effects. These included low levels of certain white blood cells in 15% of patients, nausea in 10%, and issues like a low platelet count and another type of low white blood cell count in 30% of patients. Another study reported that about 14% of patients experienced severe side effects related to the treatment. Despite these numbers, medical support generally makes such treatments manageable. Potential participants should discuss these findings with healthcare providers to understand what they might experience. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for head and neck cancer because it combines toripalimab, an innovative immunotherapy drug, with traditional chemotherapy agents, cisplatin and docetaxel. Unlike standard treatments that primarily focus on chemotherapy or radiotherapy alone, this combination leverages the body's immune system to help fight cancer cells, potentially enhancing the overall effectiveness. Toripalimab, a PD-1 inhibitor, works by blocking a pathway that tumors use to evade the immune system, allowing for a more robust immune response against the cancer. This could offer a new avenue for patients, particularly those who might not respond as well to existing therapies.

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

In this trial, participants will receive a combination of toripalimab, cisplatin, and docetaxel as induction therapy for head and neck squamous cell carcinoma (HNSCC). Research has shown that combining toripalimab with cisplatin and docetaxel may effectively treat HNSCC. One study found that using this combination as an initial treatment improved patient outcomes. Another review highlighted that this approach, which combines chemotherapy and immune therapy, can be more effective than traditional methods while maintaining similar safety levels. Early data suggests that adding toripalimab, a type of immune therapy, helps the body's immune system better attack cancer cells. Overall, these findings offer hope that this treatment combination could be a strong option for those with advanced HNSCC. ^{1 2 4 5 6}

Who Is on the Research Team?

Thomas Roberts, MD, MBA

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with a new diagnosis of certain types of head and neck squamous cell carcinoma (HNSCC), who have not yet received treatment. They should be expected to live more than 12 weeks, able to consent, have specific cancer stages depending on HPV status, and meet health criteria including organ function. Pregnant women or those on investigational drugs for HNSCC are excluded.

Inclusion Criteria

Life expectancy of greater than 12 weeks

Ability to understand and sign a written informed consent document

CPS ≥ 1%

Exclusion Criteria

Pregnant or breastfeeding women

Participants receiving any other investigational agents for this condition

History of allergic reactions to specific compounds

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants receive toripalimab in combination with cisplatin and docetaxel for up to 3 cycles

9 weeks

3 visits (in-person, every 21 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• Docetaxel
• Toripalimab-tpzi

Trial Overview The study tests the safety and effectiveness of toripalimab combined with cisplatin and docetaxel as an initial therapy in patients with CPS-positive locally advanced HNSCC. It aims to see how well patients tolerate this combination before they undergo other treatments like surgery or radiation.

How Is the Trial Designed?

Group I: PDT (cisplatin + docetaxel + toripalimab) induction therapy Experimental Treatment 3 Interventions

Toripalimab, cisplatin, and docetaxel will be given once every 21 days, +/- a window of 5 days, by intravenous infusion. On day 1 of each cycle, the pre-determined dose of toripalimab will be administered over about 60 minutes. The pre-determined dose of docetaxel will then be administered over about 1 hour. After docetaxel, the pre-determined dose of cisplatin will be administered over about 1-3 hours. This will continue for up to 3 cycles. Participants may be pre-medicated with drugs to reduce the chance of having a sensitivity reaction to the study treatment. The decision to pursue definitive chemoradiotherapy should be made by a multidisciplinary team specializing in treating head and neck cancers. For patients receiving chemoradiotherapy, the recommended concurrent chemotherapy regimen used with radiotherapy is weekly cisplatin.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Coherus Oncology, Inc.

Industry Sponsor

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.6070

Induction therapy of toripalimab combined with docetaxel ... All patients received 2 cycles of intravenous docetaxel (75mg/m2), cisplatin (75mg/m2) and toripalimab (240mg) on day 1 every 21 days, followed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07214987

PDT For Induction Therapy For Head And Neck Cancer This research study is being done to assess the safety and tolerability of toripalimab in combination with cisplatin and docetaxel (PDT) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11699790/

The efficacy and safety of a taxane-based chemotherapy ... This study aims to elucidate the therapeutic efficacy and safety of a taxane-based chemotherapy in combination with immune checkpoint inhibitors regimen

4. sciencedirect.com sciencedirect.com/science/article/pii/S1043661825000234

Neoadjuvant chemoimmunotherapy for locally advanced ... This systematic review and meta-analysis demonstrated that neoadjuvant chemoimmunotherapy offered superior efficacy and similar safety compared to neoadjuvant ...

5. jeccr.biomedcentral.com jeccr.biomedcentral.com/articles/10.1186/s13046-022-02510-2

Neoadjuvant toripalimab combined with gemcitabine and ... The trial demonstrated favorable toxicity and improved efficacy of neoadjuvant gemcitabine and cisplatin combined with toripalimab in patients ...

6. asco.org asco.org/abstracts-presentations/ABSTRACT249081

Safety and efficacy of docetaxel combined with cisplatin as ... The most frequent grade 3–4 toxicities were neutropenia (3/20,15%) and nausea (2/20,10%) after ICT and thrombocytopenia (6/20,30%) and leukopenia (6/20,30%) ...