Anti-PD-1 Antibody in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract

Study Purpose

This is a single-center, open-label, single-arm phase II clinical study to exploratory observe and evaluate the efficacy and safety of anti-PD-1 antibody (Camrelizumab for Injection) in patients with malignant melanoma of the female genital tract. Subjects were to have a safety visit 3 days prior to dosing in each treatment cycle after the study. Imaging was performed every 8 weeks to assess efficacy until radiographic progression, initiation of new antineoplastic therapy, withdrawal of consent, or subject lost to follow-up/death. After the end of treatment, an end-of-treatment visit and a post-treatment safety visit will also be performed. After the end of treatment, subjects will also be followed up for survival (every 3 months for years 1 to 2, every 4 months for years 3, every 6 months for years 4 to 5, and annually from year 6) to collect and record the survival status of subjects and subsequent anti-tumor treatment.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients voluntarily join this study and sign the informed consent form; - Age: women aged 18 to 70 years; - Cohort 1 patients need to meet: radical surgery in our hospital or other hospital, no gross residual lesions or imaging metastases; and our hospital surgical histopathology (or pathology consultation in our hospital) confirmed as patients with primary genital tract melanoma (vulva, vagina, cervix or uterine body origin); for vulvar malignant melanoma: postoperative pathology suggests tumor breslow thickness ≥ 1.5 mm or lymph node metastasis, in line with any of the above can be enrolled; for vaginal malignant melanoma: postoperative pathology suggests tumor diameter > 3 cm, depth of invasion ≥ 1/2 or tumor breslow thickness ≥ 2 mm, lymph node metastasis, in line with any of the above can be enrolled; for cervical or uterine body malignant melanoma: all patients after radical surgery can be enrolled.
Cohort 2 patients should meet: patients with primary female genital tract melanoma confirmed by histopathology (or pathology consultation in our hospital), who are recurrent metastatic disease or unresectable after initial treatment, and have at least one measurable lesion (RECIST version 1.1);
  • - If the investigator considers that the scope of surgery is too large, patients can be considered for neoadjuvant anti-PD-1 antibody therapy (no more than 4 cycles) + interval surgery + postoperative adjuvant anti-PD-1 antibody therapy: patients receiving neoadjuvant therapy must receive interval surgery after 3-4 cycles of treatment.
Confirmation of pathological diagnosis using mandatory biopsy tissue samples (e.g. obtained by hollow core needle, biopsy, excision, etc.);
  • - 5-10 formalin-fixed, paraffin-embedded tumor tissue sections from lesions that can be obtained (not required) for biomarker analysis; - ECOG-PS score: 0-1; - Expected survival time ≥ 12 weeks; - Bone marrow function: neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L; - Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal; AST and ALT ≤ 2.5 times the upper limit of normal or the presence of liver metastasis ≤ 5 times the upper limit of normal; total bilirubin ≤ 1.5 times the upper limit of normal, or patients with Gilbert's syndrome ≤ 2.5 times the upper limit of normal; - Non-surgically sterilized subjects of childbearing age must agree to take effective contraceptive measures during the study treatment and within 3 months after the end of the study treatment period; Non-surgically sterilized women of childbearing age must have a negative serum or urine pregnancy test before the study; - Non-lactating patients.

Exclusion Criteria:

  • - Patients with central nervous system disease or brain metastases; patients who have received systemic, radical treatment of brain or meningeal metastases (radiotherapy or surgery), such as imaging confirmed stable has been maintained for at least 1 month, and have stopped systemic hormone therapy (dose > 10 mg/day prednisone or other effective hormones) for more than 2 weeks, no clinical symptoms can be included; - Other malignant tumors occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer; - The researchers believe that will affect the ability of subjects to receive the study program treatment, and uncontrolled serious medical diseases, such as severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension (after treatment: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, Based on the average of BP readings obtained by ≥ 2 measurements), uncontrolled infection, active peptic ulcer, etc.; - Known interstitial lung disease or history or evidence of non-infectious pneumonia treated with corticosteroids; or patients who may interfere with the detection or treatment of suspected drug-related pulmonary toxicity; - Known allergy, high sensitivity or intolerance to study-related drugs or their excipients; - received other experimental drugs or participated in other clinical studies for the purpose of anti-cancer therapy within 30 days before the first dose; - Serious infection occurred before the start of study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia or severe pneumonia; - Previously received anti-programmed cell death-1 (PD-1), anti-PD-L1, anti-CD137 or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody therapy; - 7 days before receiving the study drug, diagnosed with immunodeficiency disease or receiving systemic steroid therapy or other immunosuppressive therapy; - patients with active pulmonary tuberculosis; - syphilis patients; - human immunodeficiency virus (HIV) positive; - hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) test ≥ 1 × 103 IU/mL subjects; if HBsAg positive, and peripheral blood HBV-DNA < 1 × 103 IU/mL, if the investigator believes that the subject is in a stable period of chronic hepatitis B and will not increase the risk of subjects, Subjects are eligible; - Hepatitis C virus (HCV) antibody positive and HCV RNA test positive.
- less than 4 years before the study medication or may be vaccinated during the study; - the researchers determine that patients who are not suitable for this study, such as alcoholism, drug abuse, other serious diseases (including mental illness) need combined treatment, there are serious laboratory abnormalities, accompanied by family or social factors, will affect the safety of patients or data and sample collection;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04593485
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fudan University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Xiaohua Wu
Principal Investigator Affiliation Fudan University Shanghai Cancer Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Melanoma
Additional Details

This is a single-center, open-label, single-arm phase II clinical study to exploratory observe and evaluate the efficacy and safety of anti-PD-1 antibody (Camrelizumab for Injection) in patients with malignant melanoma of the female genital tract. The patients were divided into two cohorts according to their conditions: Cohort 1: patients with postoperative recurrence of malignant melanoma of the female genital tract requiring adjuvant therapy;Cohort 2: patients with metastatic or unresectable malignant melanoma of the female genital tract who were screened eligible and received study treatment after being fully informed and signing the informed consent form. Camrelizumab will be administered at a fixed dose of 200 mg intravenously (iv) on D1 in a 14-day cycle. All subjects will be administered until they reach the end of treatment standard specified in the protocol. Subjects were to have a safety visit 3 days prior to dosing in each treatment cycle after the study. Imaging was performed every 8 weeks to assess efficacy until radiographic progression, initiation of new antineoplastic therapy, withdrawal of consent, or subject lost to follow-up/death. After the end of treatment, an end-of-treatment visit and a post-treatment safety visit will also be performed. Subjects who have concluded the study treatment for reasons other than disease progression will receive imaging assessment at the end of treatment (if imaging evaluation is not performed at 4 months) and imaging assessment every 3 months after the end of treatment to assess the time to disease progression. After the end of treatment, subjects will also be followed up for survival (every 3 months for years 1 to 2, every 4 months for years 3, every 6 months for years 4 to 5, and annually from year 6) to collect and record the survival status of subjects and subsequent anti-tumor treatment. Tumor tissue samples, sections, paraffin blocks or biopsy blocks, and biomarkers, including but not limited to PD-L1 expression level and the proportion of positive cells, TMB level and MMR status, will be collected from subjects during the screening period after the most recent previous treatment.

Arms & Interventions

Arms

Experimental: Cohort 1

patients with postoperative recurrence of malignant melanoma of the female genital tract requiring adjuvant therapy, Camrelizumab for injection

Experimental: Cohort 2

patients with metastatic or unresectable malignant melanoma of the female genital tract, Camrelizumab for injection

Interventions

Drug: - Camrelizumab for injection

Carrelizumab will be administered at a fixed dose

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Status

Recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, 200032

Site Contact

xiaohua wu

alizheng@126.com

+86 18017312352

Fudan University Shanghai Cancer Center, Shanghai, China

Status

Recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai, ,

Site Contact

xiaohua wu

alizheng@126.com

+86 18017312352

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