Study of Radiotherapy Administered in Combination With Ipilimumab in

Status Terminated

Clinical Trial Summary

RATIONALE:Anti-melanoma activity of Ipilimumab both as a single therapy and in association with melanoma peptides has been shown as well as synergy between radiation therapy and anti-CTLA-A mAb in several tumor animal models for both local tumor control and distant effects.Radiotherapy increases tumor immunogenicity in several preclinical models by increasing MHC molecules expression and is able to induce significant tumor reduction in around 30% of cases. Thus, combining radiotherapy and administration of ipilimumab could elicit systemic antitumor response. Radiation therapy will expose tumor-associated antigens (TAA) and facilitate antigen presentation, and further blockade of CTLA-4 could amplify the immune antitumor response. In this therapeutical model, the use of the own patient tumor as a source of tumor antigens (in opposition with other vaccination protocols, where TAA are exogenic) is particularly adapted.

PURPOSE: This Phase I trial determines the side effects and best dose of radiation therapy administered in combination with ipilimumab.

Clinical Trial Description

OBJECTIVES:

Primary: To determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and recommended Phase 2 dose of radiation therapy administered in combination with ipilimumab.

Secondary:

Adverse event profiles Preliminary anti-tumor activity following escalating doses of radiation combined to ipilimumab using the immune related response criteria irRC overall survival in patients treated with this combination systemic immunologic anti tumor response intratumoral immune response pharmacodynamic effects of ipilimumab and radiotherapy in combination on Absolute Lymphocyte Count (ALC) associations between ALC and anti-tumor activity of ipilimumab and radiotherapy in combination ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01557114
Study type	Interventional
Source	Gustave Roussy, Cancer Campus, Grand Paris
Contact
Status	Terminated
Phase	Phase 1
Start date	March 2011
Completion date	March 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04229277` - Fast Track Diagnosis of Skin Cancer by Advanced Imaging	N/A
Completed	`NCT03653819` - High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs	N/A
Active, not recruiting	`NCT04074096` - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis	Phase 2
Completed	`NCT02935790` - Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab	Phase 1
Recruiting	`NCT05478876` - Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract	N/A
Completed	`NCT01211262` - Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma	Phase 1
Recruiting	`NCT03649529` - Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy	Early Phase 1
Completed	`NCT03278665` - 4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy	Phase 1/Phase 2
Completed	`NCT04452214` - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors	Phase 1
Terminated	`NCT02709889` - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors	Phase 1/Phase 2
Completed	`NCT01455259` - Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors	Phase 1/Phase 2
Completed	`NCT00978913` - Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma	Phase 1
Completed	`NCT00232726` - Clinical Study of Previously Untreated Patients With Malignant Melanoma	Phase 2
Completed	`NCT00350597` - GM-CSF as Adjuvant Therapy of Melanoma	Phase 2
Completed	`NCT00336986` - Efficacy Study of IL-21 to Treat Metastatic Melanoma	Phase 2
Completed	`NCT02523313` - Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED	Phase 2
Completed	`NCT03545334` - Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study	N/A
Completed	`NCT04253574` - Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
Completed	`NCT00179608` - Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy	Phase 1
Terminated	`NCT00104884` - FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of Radiotherapy Administered in Combination With Ipilimumab in Patients With Unresectable Stage III or Stage IV Advanced Malignant Melanoma — Mel-Ipi-Rx

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms