Malignant MelanomaPhase 2NCT04593485
Anti-PD-1 Antibody in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract
A Phase 2 study testing Camrelizumab for injection in people with Malignant Melanoma, run by Fudan University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Camrelizumab for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 28 Oct 2020to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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 locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
xiaohua wu
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
xiaohua wu
About this study
Official title: Single-center, Open-label, Single-arm Phase II Clinical Trial of Anti-PD-1 Antibody (Camrelizumab for Injection) in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract
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.
Read the detailed description
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.
- Conditions
- Malignant Melanoma
- Being tested
- Camrelizumab for injection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab for injectionDrug
Also called Jiangsu Hengrui, SHR-1210
Carrelizumab will be administered at a fixed dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | patients with postoperative recurrence of malignant melanoma of the female genital tract requiring adjuvant therapy, Camrelizumab for injection Receives: Drug: Camrelizumab for injection |
| Cohort 2 | Experimental | patients with metastatic or unresectable malignant melanoma of the female genital tract, Camrelizumab for injection Receives: Drug: Camrelizumab for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
The primary endpoint for Cohort 1 is relapse-free survival (RFS)
Measured: RFS was defined as the time from surgery to first local, regional, or distant tumor recurrence or death from any cause, whichever came first, assessed up to one year.
Objective Response Rate (ORR)
The primary endpoint for Cohort 2 is Objective Response Rate (ORR)
Measured: Tthrough study completion, an average of 2 year.
Secondary outcomes (1)
Adverse events (AEs)
according to NCI-CTCAE v5.0
Measured: Through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start28 Oct 2020
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaohua Wu, Principal investigator, Fudan University Shanghai Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593485
- Sponsor's protocol ID
- 2020-GYN-006
- Status last verified
- Dec 2020
- First submitted
- 18 Aug 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open-label, Single-arm Phase II Clinical Trial of Anti-PD-1 Antibody (Camrelizumab for Injection) in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract
- ClinicalTrials.gov ID
- NCT04593485
- Acronym / sponsor ID
- 2020-GYN-006
- Conditions
- Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Camrelizumab for injectionpatients with postoperative recurrence of malignant melanoma of the female genital tract requiring adjuvant therapy, Camrelizumab for injection |
| Cohort 2 | Experimental | Drug: Camrelizumab for injectionpatients with metastatic or unresectable malignant melanoma of the female genital tract, Camrelizumab for injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab for injectionAlso: Jiangsu Hengrui, SHR-1210Carrelizumab will be administered at a fixed dose | Drug | Cohort 1, Cohort 2 |
Primary outcome
Relapse-free survival (RFS)
Time frame: RFS was defined as the time from surgery to first local, regional, or distant tumor recurrence or death from any cause, whichever came first, assessed up to one year.
The primary endpoint for Cohort 1 is relapse-free survival (RFS)
Objective Response Rate (ORR)
Time frame: Tthrough study completion, an average of 2 year.
The primary endpoint for Cohort 2 is Objective Response Rate (ORR)
1 secondary outcome
Adverse events (AEs)
Time frame: Through study completion, an average of 2 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohua Wu principal investigator
Fudan University Shanghai Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab for injection in people with Malignant Melanoma, run by Fudan University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Wu, MD,PhD (+86 18017312352, alizheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) (time frame: RFS was defined as the time from surgery to first local, regional, or distant tumor recurrence or death from any cause, whichever came first, assessed up to one year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.