NL-OMON54971
Recruiting
Not Applicable
Multicenter Phase 1b trial testing the Neoadjuvant Combination of Domatinostat, Nivolumab, and Ipilimumab, in IFN-gamma signature-low and IFN-gamma signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma -DONIMI. - DONIMI
Antoni van Leeuwenhoek Ziekenhuis0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Adults at least 18 years of age.
- •\- World Health Organization (WHO) Performance Status 0 or 1\.
- •\- Cytologically or histologically confirmed resectable stage III cutaneous
- •melanoma (unknown primary also allowed) with one or more macroscopic lymph node
- •metastases (measurable according to RECIST 1\.1\), that can be biopsied, and no
- •history of in\-transit metastases within the last 6 months.
- •\- IFN\-gamma signature low or high according to the NanoString test (IFN\-gamma
- •signature intermediate not allowed).
- •\- No other malignancies, except adequately treated and a cancer\-related
- •life\-expectancy of more than 5 years.
Exclusion Criteria
- •\- Distantly metastasized melanoma.
- •\- Uveal or mucosal melanoma.
- •\- History of in\-transit metastases within the last 6 months.
- •\- No measurable lymph node lesion according to RECIST 1\.1\.
- •\- Subjects with any active autoimmune disease or a documented history of
- •autoimmune disease, or history of syndrome that required systemic steroids or
- •immunosuppressive medications, except for subjects with vitiligo or resolved
- •childhood asthma/atopy.
- •\- Patients with any active gastrointestinal disorder that could interfere with
- •the absorption of domatinostat (as per judgement of the investigator), such as
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Multicenter Clinical Trial of Neoadjuvant Therapy for Locally Advanced Rectal Cancer by Chemoradiation Combined with MetformiRectal cancerJPRN-jRCTs011200001Taketomi Akinobu64
Active, not recruiting
Not Applicable
Phase II trial assessing neoadjuvant therapy with FEC 100 followed by Taxotere® (docetaxel) plus Vectibix® (panitumumab) in patients with operable, HR and Her-2 negative breast cancer. TVA study. - TVA studyRH- and Her2- operable breast cancer, in neoadjuvant situationMedDRA version: 9.1Level: LLTClassification code 10022882Term: Invasive ductal breast cancerEUCTR2009-012853-39-FRCentre Jean Perrin
Recruiting
Phase 2
Phase II multicenter trial of neoadjuvant chemotherapy followed by radical hysterectomy and adjuvant chemotherapy by irrinotecan hydrochloride and nedaplatin for the patients with stage Ib2-IIb bulky cervical cancer (tumor diameter > 4 cm): OGSK_KCOG-G1201JPRN-UMIN000008023The Obstetrical and Gynecological Society of Kinki District Japan and the Kansai Clinical Oncology Group68
Active, not recruiting
Phase 1
Phase II single-arm study evaluating abiraterone acetate (plus prednisolone) and Gonadotropin-Releasing Hormone (GnRH) agonist prior to receiving radical radiotherapy in high risk localised prostate carcinoma patientsHigh-risk prostate cancerMedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-001128-31-IECancer Trials Ireland36
Completed
Phase 2
Multicenter phase II trial of neoadjuvant chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinomaoral squamous cell carcinomaJPRN-C000000023Chubu research group on oral cancer30