KCT0004145Not yet recruiting未知
The combination of anti-PD-1 blockade with radiotherapy in previously untreated metastatic melanoma
Yonsei University Health System, Severance Hospital0 sites52 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Enrollment
- 52
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- •2. Male or female age = 20 years at the time of informed consent
- •3. Histologically confirmed diagnosis of malignant melanoma
- •4. unresectable stage IIIB, IIIC, IVM1a, IVM1b or IVM1c melanoma
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •6. Screening labs performed within 14 days of randomization demonstrating adequate hematologic, coagulation, liver, and kidney functions
- •7. Indications for radiotherapy
- •8. BRAF status must be checked, but patient is eligible regardless of BRAF mutations (BRAF V600 mutation positive patients are eligible)
Exclusion Criteria
- •1. Ocular melanoma
- •2. Active, uncontrolled brain metastasis (requires 1 month of washout period radiation therapy, surgery or gamma-knife surgery)
- •3. Previous treatment with chemotherapy, a CTLA-4 or PD-1/PD-L1 antagonist agent, including treatment in adjuvant setting for immunotherapy
- •4. Concurrent medical disease which would significantly limit full compliance with the study such as, but not limited to the following: heart failure (III, IV as per NYHA classification), renal insufficiency, active infection (requires negative gest for clinically suspected HIV, hepatitis B virus, hepatitis C virus).
- •If positive results are not indicative of true active or chronic infection, the subject may enter the study after discussion and agreement between the investigator and medical director.
- •5. Has known malignancy diagnosed within three years that is progressing and requires active treatment are excluded.
- •6. Autoimmune disease requiring chronic treatment with systemic corticosteroids or any other immunosuppressive agents 7 days prior to inclusion
- •-Exception: intranasal glucocorticoid and intra-articular steroid injections
- •-Exception: administration of prednisolone 10mg/day or equivalent as physiologic dose for adrenal insufficiency
- •-Exception: steroid as pre-medication to prevent anaphylactic shock (contrast with CT, other systemic treatment)
- •8. Has known psychiatric or substance abuse disorders that would interfere with cooperation requirements of the trial
- •9. Lack of availability for clinical follow-up assessments
Investigators
Similar Trials
Active, not recruiting
Phase 1
Fostering efficacy of anti – PD-1 – treatment: Nivolumab plus radiotherapy in advanced NSCLCmetastatic non-squamous Non-Small Cell Lung Cancer (Lung adenocarcinoma metastatic and Large cell lung cancer metastatic)MedDRA version: 21.1Level: PTClassification code 10069730Term: Large cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10064049Term: Lung adenocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005741-31-DEAIO-Studien-gGmbH130
Completed
Not Applicable
Combination of checkpoint inhibitor and radiotherapy for recurrent gastric cancer after initial treatment with standard therapy.Gastric cancerJPRN-UMIN000031508Fukushima Medical University41
Recruiting
Not Applicable
Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy. DURIPANC study.metastatic pancreatic cancermetastatic pancreatic ductal adenocarcinoma1001567410017991NL-OMON56232Erasmus MC, Universitair Medisch Centrum Rotterdam43
Recruiting
Phase 1
Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy. DURIPANC StudyMetastatic pancreatic cancerMedDRA version: 27.0Level: LLTClassification code: 10033605Term: Pancreatic cancer metastatic Class: 10029104CTIS2024-514597-42-00Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)43
Active, not recruiting
Phase 1
udwigOesophageal CancerMedDRA version: 20.0Level: LLTClassification code 10026180Term: Malignant neoplasm of oesophagusSystem Organ Class: 100000004864EUCTR2015-005298-19-GBudwig Institute for Cancer Research Ltd.75