Neoadjuvant Chemotherapy + PD-1 Inhibition for Head and Neck Cancer

((NeoScorch HN) Trial)

Overseen By Zubair Khan, MBBS, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: PD-1 inhibitors, Steroids

Disqualifiers: Pregnancy, Autoimmune disease, HIV, others

Stay on Your Current Meds You can continue your current medications while participating

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: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of chemotherapy and immunotherapy using the drug Toripalimab for individuals with advanced head and neck cancers. Researchers aim to determine if this approach can improve treatment outcomes before surgery. The trial includes three groups based on the specific type and location of the cancer, such as its relation to HPV (a virus linked to some cancers) or involvement of critical areas like the sinus and skull. Ideal participants are those with confirmed head and neck cancer who have not received previous treatments for their current cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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

Research has shown that toripalimab, a type of medication, is generally safe for patients. Most immune-related side effects are mild to moderate, with serious side effects being less common.

When combined with chemotherapy drugs like cisplatin and docetaxel, toripalimab remains safe. One study found that this combination effectively treats advanced cancers.

Another study found that most patients responded positively to this treatment, leading to its approval for some types of cancer. This indicates that the treatment is generally safe.

Overall, evidence suggests that toripalimab and its combinations are safe, with most side effects being manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Toripalimab for head and neck cancer because it represents a novel approach compared to traditional treatments like surgery, radiation, and chemotherapy. Toripalimab is a PD-1 inhibitor, which means it works by boosting the body's immune system to better recognize and attack cancer cells, unlike standard treatments that directly target the cancer cells themselves. Additionally, combining Toripalimab with chemotherapy drugs like Cisplatin and Docetaxel before surgery might enhance the treatment's effectiveness by shrinking tumors more effectively. This innovative combination offers hope for improving outcomes and potentially leading to longer-lasting remission for patients.

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

In this trial, participants will receive various treatment combinations involving toripalimab. Studies have shown that toripalimab, when combined with chemotherapy, can effectively treat advanced head and neck cancer. Specifically, one study found that 53.7% of patients with advanced cancer responded to this treatment. In this trial, some participants will receive neoadjuvant chemotherapy with toripalimab and either cisplatin or carboplatin plus docetaxel before surgery. Others will receive toripalimab after surgery and chemotherapy, which has been linked to longer periods without cancer growth. These findings suggest that toripalimab, particularly when combined with chemotherapy, may better control head and neck cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Nyall R London, MD, Ph.D

Principal Investigator

Otolaryngology - Broadway

Are You a Good Fit for This Trial?

Inclusion Criteria

Platelets ≥100,000/µL

Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total >1.5 × ULN (Upper Limit of Normal)

My cancer is caused by HPV16 only.

Exclusion Criteria

I have not had a live vaccine in the past 30 days.

I have not had another cancer needing treatment in the past 2 years, except low-risk types.

Concurrent treatment with other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant chemotherapy with Toripalimab and either Cisplatin or Carboplatin, along with Docetaxel

6-8 weeks

Surgery

Participants undergo surgical treatment with potential de-escalation based on response

1-2 weeks

Adjuvant Treatment

Participants receive adjuvant radiation or chemoradiotherapy, followed by treatment with Toripalimab

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Toripalimab
• Toripalimab + Chemotherapy

How Is the Trial Designed?

Group I: Rad+/-Chem : Adjuvant radiation or chemoradiotherapy Experimental Treatment 1 Intervention

Radiation or Chemotherapy will be given after the surgery

Group II: Neo + Surg : Neoadjuvant Treatment and surgery Experimental Treatment 1 Intervention

Neoadjuvant Chemotherapy with * Toripalimab + Cisplatin + Docetaxel OR * Toripalimab + Carboplatin + Docetaxel

Group III: Adjuvant (ADJ) treatment Experimental Treatment 1 Intervention

Treated with Toripalimab after adjuvant treatment

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Coherus Oncology, Inc.

Industry Sponsor

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e18097

Updated results of adjuvant toripalimab for locally ...

The preliminary results highlighted that adjuvant toripalimab for LA-HNSCC patients who achieved pCR after NICT and surgery showed encouraging efficacy and ...

2.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(24)02446-3/fulltext

865P Adjuvant toripalimab for locally advanced head and ...

For LA-HNSCC patients who achieved pCR after NICT and surgery, adjuvant immunotherapy with toripalimab showed promising efficacy and tolerable toxicity.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12127343/

Neoadjuvant toripalimab combined with chemotherapy ... - PMC

To determine the safety and efficacy of neoadjuvant toripalimab combined with chemotherapy in locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2543106426000104

Harnessing toripalimab-tpzi as a PD-1 checkpoint inhibitor

In the Phase I-III clinical trials on recurrent or metastatic HNSCC, the objective response rates of toripalimab-tpzi were around 20-36, the median progression- ...

5.

ascopubs.org

ascopubs.org/doi/pdf/10.1200/JCO.2025.43.16_suppl.e18097

Updated results of adjuvant toripalimab for locally ...

Conclusions: The preliminary results highlighted that adjuvant toripalimab for LA-HNSCC patients who achieved pCR after NICT and surgery showed encour- aging ...

6.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(24)02452-9/fulltext

872P Safety and efficacy of toripalimab combined with ...

The estimated median OS was 18.1 (95% CI 10.6, NE) months and 1-year OS rate was 62.2%. 40 (93.0%) patients experienced treatment-related adverse events, with ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12522217/

Safety and efficacy of toripalimab plus concurrent ... - PMC

In this trial, all 30 patients responded to a combination regimen that included toripalimab and CCRT. The 2-year PFS rate was 90%; median PFS ...

8.

jitc.bmj.com

jitc.bmj.com/content/11/Suppl_1/A769

678 Updated safety and efficacy of toripalimab combined ...

Toripalimab combined with cetuximab were well tolerated and showed promising clinical efficacy in patients with R/M HNSCC.

9.

cancernetwork.com

cancernetwork.com/view/expert-discusses-safety-of-toripalimab-in-advanced-nasopharyngeal-carcinoma

Expert Discusses Safety of Toripalimab in Advanced ...

Treatment with toripalimab does not yield the same vascular toxicity seen with pembrolizumab in patients with advanced or metastatic nasopharyngeal carcinoma.