the Efficacy and Safety of PD-1 Inhibitors With or Without Radiotherapy in Patients With Advanced MelanomaPhase 2NCT05498805
PD-1 Inhibitors With or Without Radiation in Advanced Melanoma
A Phase 2 study testing Radiation in people with the Efficacy and Safety of PD-1 Inhibitors With or Without Radiotherapy in Patients With Advanced Melanoma, run by Fudan University at 1 site in China.
Trial summary
This trial was a single-center, prospective, randomized controlled phase II trial. The objective was to evaluate the efficacy and safety of PD-1 inhibitors with or without radiotherapy in patients with advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Efficacy and Safety of PD-1 Inhibitors With or Without Radiotherapy in Patients With Advanced Melanoma
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2022to 15 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years old, both sexes;
- Malignant melanoma was confirmed by histology and pathology.
- Braf, Nras, Ckit gene mutation status is unlimited.
- Unresectable or metastatic melanoma, no matter lines of treatment;
- Eastern Oncology Collaborative Group (ECOG) body condition score (PS) 0-2;
- Predicted survival time exceeds 3 months.
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- Within 7 days (including 7 days) before screening, laboratory test data were used to obtain neutrophil count ≥1.5×109/L, platelet count ≥90×109/L, hemoglobin ≥90g/L (no blood transfusion within 14 days), and serum total bilirubin ≤1.25 times upper limit of normal (ULN). ALT and AST≤ 2.5 x ULN (≤ 5X ULN in patients with liver metastases); Serum creatinine ≤1.25 x ULN;
- At least one radiotherapable lesion;
- Subjects (or their legal representative/guardian) must sign an informed consent form stating that they understand the purpose of the study, understand the required procedures, and are willing to participate in the study.
Who cannot join
- Received any investigational or antitumor drugs within 4 weeks prior to enrollment;
- A history of other tumors within the past five years, except cured cervical cancer or basal cell carcinoma of the skin;
- A tumor emergency that requires immediate radiotherapy, such as symptomatic brain or meningeal metastases, bone-related events, etc.
- clinically significant active bleeding;
- a woman who is pregnant or breastfeeding; Persons who are fertile but do not take adequate contraceptive measures;
- Alcoholism or drug addiction;
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- with active, or have a history and are likely to relapse of patients with autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerular inflammation, etc.), or high risk (e.g., received organ transplants on immunosuppressive therapy) of the patients. Exceptions are autoimmune hypothyroidism that requires only hormone replacement therapy or skin conditions that do not require systemic treatment.
- patients who required systemic treatment with corticosteroids (doses equivalent to > 10mg prednisone/day) or other immunosuppressive agents within 14 days prior to enrollment or during the study. Use topical or inhaled glucocorticoids, or short-term (≤7 days) glucocorticoids for the prevention or treatment of non-autoimmune, infrequently occurring allergic diseases.
- Critical organ failure or other serious disease, including interstitial pneumonia, clinically relevant coronary disease, cardiovascular disease, or a history of myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia in the 6 months prior to enrollment;
- Have a history of human immunodeficiency virus infection, another acquired or congenital immunodeficiency disease, or a history of organ transplantation, or stem cell transplantation;
- A patient with active chronic hepatitis B or active hepatitis C. HBV carriers, medically stable hepatitis B (DNA titer ≤103 copies /ml), and cured hepatitis C (HCV RNA negative) patients were eligible for enrollment.
- A history of severe neurological or psychiatric problems; Severe infection; Active disseminated intravascular coagulation or other comorbidities that, in the investigator's judgment, seriously compromise patient safety or interfere with study completion.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cencer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Randomized Controlled Phase II Trial of PD-1 Inhibitors With or Without Radiation in Patients With Advanced Melanoma
This trial was a single-center, prospective, randomized controlled phase II trial. The objective was to evaluate the efficacy and safety of PD-1 inhibitors with or without radiotherapy in patients with advanced melanoma. At the same time, tissue and peripheral blood samples of patients were collected for the determination of PD-L1 expression, ctDNA and other biomarkers and results analysis to find prognostic or curative effect predictors. A total of 92 patients were planned to be enrolled in this study.
Patients with advanced melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in the study and received PD-1 inhibitors with or without radiotherapy.
- Being tested
- Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
According to the lesion sites, SBRT or hyperfractionated radiotherapy was used.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | PD-1 inhibitor combined with radiotherapy, whether PD-1 inhibitor was used alone or in combination with other drugs was determined by the investigator. According to the lesion sties, SBRT or hyperfractionated radiotherapy was used. Receives: Radiation: Radiation |
| controlled group | Active comparator | PD-1 inhibitor without radiotherapy, whether PD-1 inhibitor was used alone or in combination with other drugs was determined by the investigator. Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start15 Aug 2022 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Efficacy and Safety of PD-1 Inhibitors With or Without Radiotherapy in Patients With Advanced 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- radiation
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498805
- Sponsor's protocol ID
- Fudan-MM002
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase II Trial of PD-1 Inhibitors With or Without Radiation in Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT05498805
- Acronym / sponsor ID
- Fudan-MM002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 12 Aug 2022 (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 trial was a single-center, prospective, randomized controlled phase II trial. The objective was to evaluate the efficacy and safety of PD-1 inhibitors with or without radiotherapy in patients with advanced melanoma. At the same time, tissue and peripheral blood samples of patients were collected for the determination of PD-L1 expression, ctDNA and other biomarkers and results analysis to find prognostic or curative effect predictors. A total of 92 patients were planned to be enrolled in this study.
Patients with advanced melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in the study and received PD-1 inhibitors with or without radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- radiation
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Radiation: RadiationPD-1 inhibitor combined with radiotherapy, whether PD-1 inhibitor was used alone or in combination with other drugs was determined by the investigator. According to the lesion sties, SBRT or hyperfractionated radiotherapy was used. |
| controlled group | Active comparator | Radiation: RadiationPD-1 inhibitor without radiotherapy, whether PD-1 inhibitor was used alone or in combination with other drugs was determined by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥18 years old, both sexes;
- Malignant melanoma was confirmed by histology and pathology.
- Braf, Nras, Ckit gene mutation status is unlimited.
- Unresectable or metastatic melanoma, no matter lines of treatment;
- Eastern Oncology Collaborative Group (ECOG) body condition score (PS) 0-2;
Key exclusion criteria (12 listed)
- Received any investigational or antitumor drugs within 4 weeks prior to enrollment;
- A history of other tumors within the past five years, except cured cervical cancer or basal cell carcinoma of the skin;
- A tumor emergency that requires immediate radiotherapy, such as symptomatic brain or meningeal metastases, bone-related events, etc.
- clinically significant active bleeding;
- a woman who is pregnant or breastfeeding; Persons who are fertile but do not take adequate contraceptive measures;
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 |
|---|---|---|
| RadiationAccording to the lesion sites, SBRT or hyperfractionated radiotherapy was used. | Radiation | controlled group, experimental group |
Primary outcome
progression free survival
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation in people with the Efficacy and Safety of PD-1 Inhibitors With or Without Radiotherapy in Patients With Advanced Melanoma, run by Fudan University at 1 site 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 9 inclusion and 12 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 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 7 months). 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 12 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.