NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy...
RadiotherapyImmunotherapy9 moreThe 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.
Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic...
Metastatic MelanomaThe main purpose of this study is to determine the safety of combining ipilimumab and nivolumab with hypofractionated radiotherapy to a single tumor in patients with metastatic melanoma. Another purpose of this study is to determine the effect of ipilimumab, nivolumab and hypofractionated radiotherapy on the cancer as compared to ipilimumab and nivolumab.
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With...
Clinical Stage 0 Cutaneous Melanoma AJCC v8Clinical Stage I Cutaneous Melanoma AJCC v842 moreThis trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.
CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC...
Non Small Cell Lung CancerTriple Negative Breast Cancer2 moreThe objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors
Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma...
MelanomaThis study evaluates whether it is safe to administer a peptide vaccine (6MHP) with adjuvants and the CDX-1127 monoclonal antibody, and whether the adjuvants and the CDX-1127 monoclonal antibody boost immune responses to the vaccine. In this study, the adjuvants are Montanide ISA-51 and polyICLC. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and tissue from a vaccine site.
Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in...
MelanomaSubstudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.
OH2 Injection in Solid Tumors
Solid TumorMelanomaThis phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma). OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.
Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390...
MelanomaThe study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.
Anti-PD-1 Antibody in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract...
Malignant MelanomaThis 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.
Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma
Metastatic MelanomaBRAF Gene MutationThis is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal is to assess the toxicity and tolerability and determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the combination of nilotinib with dabrafenib and trametinib. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and nilotinib when used in combination.