High-risk Recurrent or Second Primary HNSCC With PD-1 Antibody Adjuvant After Salvage Surgery(RePASS) (RePASS)

High-risk Recurrent or Second Primary HNSCC With PD-1 Antibody Adjuvant After Salvage Surgery: The RePASS Study

This is a non-randomized, phase II, open-label study. The goal of this clinical research study is to investigate the efficacy and safety of adjuvant Toripalimab in high-risk recurrent/secondary HNSCC after salvage surgery.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Toripalimab

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Shanghai Ninth People's Hospital
      • Contact: Shengjin Dou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or second primary squamous cell carcinoma (SCC) of the head and neck. Known p16 status for oropharynx carcinoma.

  2.Patients must have had prior radiation for head and neck SCC with ≥ 75% of the present tumor volume in areas that have been previously irradiated to at least 45 Gy or the intersection between the first irradiation and the reirradiation fields had to be greater than 65%.

  3. Patients with at least one high risk factors after salvage surgery ①positive margin; ②close margin（<5mm); ③ENE;④PNI;⑤LVI; ⑤ rStaging III-IV( AJCC 8th).

  4. No macroscopic residual disease after salvage surgery.

  5.No distant metastasis.

  6.Eastern Cooperative Oncology Group Performance Status (ECOG) performance scale: 0-1.

  7.Adequate organ and bone marrow function: CBC: absolute neutrophil count (ANC) ≥ 1.5 × 10^9 / L; platelet count (PLT) ≥ 80 × 10^9 / L; hemoglobin content (HGB) ≥ 8.0 g / dL.

Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.

Renal function: serum creatinine (Cr) ≤ 1.5 × ULN.

8.Female subject of childbearing potential should have a negative urine or serum pregnancy test < 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

9.Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of study therapy through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses > 1 year.

10.Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of the study therapy.

11.Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and other requirements of the study.

Exclusion Criteria:

• 1. Women who are pregnant or lactating.

  2.Subjects with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.

  3.Subjects who are using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment.

  4.Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to randomization.

  5.There have been other malignant tumors in the past 5 years, except the cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer.

  6.Prior therapy with anti-PD-1,anti-PD-L1,anti-CTLA4 antibody.

  7.Uncontrolled concomitant disease, including but not limited to : Active or poorly controlled severe infection Human Immunodeficiency Virus (HIV) infection (HIV antibody positive) Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection Active tuberculosis Symptomatic congestive heart failure (New York Heart Association grade III-IV) or symptomatic, poorly controlled arrhythmia Uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg) Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke, and transient ischemic attack, within 6 months of enrollment.

  8.Upon the judgment by the investigator, subjects have other factors that possibly cause the halfway-termination of this study, such as other serious illnesses (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, with family or social factors, which may influence the safety of the subject, or the collection of trial data and samples.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Toripalimab; Injection; dosage form: 6ml: 240mg; frequency: 240mgQ3W; duration: 17cycles (12 months) or randomization to the date of the first documented progression	Drug: Toripalimab; Toripalimab is a type of PD-1 antibody; Other Names: JS001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year disease-free survival	from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year overall survival	from date of enrollment until date of death from any cause, assessed up to 1 year	1 year
1 year local-regional recurrence-free survival	from date of enrollment until date of first documented local-regional recurrence or death from any cause, assessed up to 1 year	1 year
1 year distant metastasis-free survival	from date of enrollment until date of first documented distant metastasis or death from any cause, assessed up to 1 year	1 year
Treatment-related adverse events (AEs)	The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v4.0 from the date of enrollment to 90 days after last dose of study treatment	from the date of enrollment to 90 days after last dose of study treatment

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Study Chair: Shengjin Dou, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2019
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 12, 2019
• First Posted (ACTUAL): October 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 12, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: PD-1; Head and neck; recurrent disease; salvage surgery; Second Primary
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2019HNRT02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No