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A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma

ConditionHead and Neck Squamous Cell Carcinoma (HNSCC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLei Liu

About this trial

A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign the informed consent voluntarily and follow the requirements of the program;

Age ≥18 years old, ≤70 years old, gender is not limited;

Physical condition score ECOG 0 or 1;

Histopathology confirmed the diagnosis of head and neck squamous cell carcinoma, and immunohistochemistry confirmed that EGFR expression was positive (defined as weak staining of > 10% of tumor cells);

Disqualifiers

Tumors originating from nasopharyngeal, paranasal, nasal or salivary glands, thyroid or parathyroid lesions, skin, unknown primary squamous cell carcinoma or non-squamous histology (e.g., mucosal melanoma);

Peripheral neuropathy ≥ grade 2 (according to CTCAE v5.0);

Received intravenous antibiotic therapy within 7 days prior to initial dosing;

Investigational drugs that have received other clinical trials within 4 weeks prior to initial dosing;

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRG003 combined with Pucotenlimab

    Drug

    Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.

  • MRG003 combined with Pucotenlimab+Cisplatin

    Drug

    All interventions all drugs intravenous infusion, once every 3 weeks, a total of 3 cycles.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: MRG003+PucotenlimabExperimental treatment 1 intervention
Group B: MRG003+Pucotenlimab+CisplatinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pCR

Pathological complete response rate

Time frame
After surgery (approximately 9-10 weeks after start of study treatment)

Secondary outcomes

1

EFS EFS

Event free survival

Time frame
1 years
2

ORR

Objective response rate

Time frame
9-10 weeks
3

OS

Overall survival

Time frame
2 years
4

Number of patients with Adverse Events (AEs)

79/5000 The incidence, severity and correlation of adverse events (AE), serious adverse events (SAE), immune-related adverse events (irAE), and laboratory index outliers were determined according to NCI-CTCAE v5.0 standards

Time frame
Up to approximately 1 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lei Liu

Lead sponsor

West China Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: