Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Ipilimumab administered alone Day 4, 25, 46, and 67

Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.

Ipilimumab will be administered alone on day 4, 25, 46 and 67.

Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67.

Radiation Therapy

Silvia C. Formenti, M.D.

An attractive area of research regards immune manipulations to recover some of the patient's immune response to his/her tumor, a strategy that has the advantages of being both natural and potentially long-lasting.\[1\] We propose to combine immunotherapy with radiotherapy directed to a metastatic site, to create a "hub" for in vivo immunization to the tumor, to enable "tumor rejection" at the other metastatic sites. This "in vivo immunization" is explored as a viable alternative to an individualized vaccine approach. Preclinical data generated by us and others support a "proof of principle" clinical trial that may open the field to an alternative use of radiotherapy in a novel partnership with cancer immunotherapy.\[2\]

In addition, we propose to perform immune-monitoring of the patients accrued to the trial to generate important information for hypothesis-driven research about the mechanisms behind the clinical findings, to be tested in the laboratory.

An attractive area of research regards immune manipulations to recover some of the patient's immune response to his/her tumor, a strategy that has the advantages of being both natural and potentially long-lasting.\[1\] We propose to combine immunotherapy with radiotherapy directed to a metastatic site, to create a "hub" for in vivo immunization to the tumor, to enable "tumor rejection" at the other metastatic sites. This "in vivo immunization" is explored as a viable alternative to an individualized vaccine approach. Preclinical data generated by us and others support a "proof of principle" clinical trial that may open the field to an alternative use of radiotherapy in a novel partnership with cancer immunotherapy.\[2\]

In addition, we propose to perform immune-monitoring of the patients accrued to the trial to generate important information for hypothesis-driven research about the mechanisms behind the clinical findings, to be tested in the laboratory.

The specific aims of the study are:

1. To explore the induction of immunity-mediated tumor response outside the radiation field (abscopal effect) after radiation/Ipilimumab in metastatic melanoma, by estimating and comparing response rates in patients treated with Ipilimumab alone (Arm A) versus ipilimumab and radiation (Arm B).
2. To compare the induction of a T-cell response in patients with metastatic melanoma treated with either ipilimumab alone or in combination with radiation.

All patients with metastatic melanoma with at least 2 measurable sites of disease are eligible. Extent of metastatic disease is recorded by CT scanning or MRI before therapy. Patients will then be randomized to Ipilimumab 3 mg/kg IV over 90 minutes alone versus Ipilimumab 3 mg/kg IV over 90 minutes plus radiotherapy to one of their measurable lesions, 6 Gy delivered daily x 5 days (Monday through Friday) (conformally or by IMRT/IGRT, to maximally spare normal tissue), for a total of 30 Gy. For patients assigned to the Ipilimumab/RT arm, Ipilimumab treatment starts after radiotherapy, with a dose given on day 4 from the first radiotherapy fraction. All patients will then have ipilimumab infusions repeated on Days 25, 46 and 67. Patients will be re-imaged (CT imaging or MRI) on Week 12 and evaluated for response (defined as an objective response of another metastatic site outside the radiation field).

The main immunological end-point will be the induction or boosting of treatment induced T cells (CD4+ and CD8+) and B cells for defined antigen approaches. In addition, the magnitude and duration of T- and B-cell responses will be examined. Treatment-induced responses will be calculated as the difference between the pre-treatment measurement and the measurement at the different time points at which blood will be collected (time of evaluation) in the same patient. The percentage of patients with the induction of treatment-induced T- and B-cell responses will be reported.

Phase II Randomized Trial of Ipilimumab Versus Ipilimumab and Radiotherapy in Metastatic Melanoma

Eligible patients have metastatic melanoma with at least 2 measurable sites of disease. All patients with metastatic melanoma are eligible to be randomly assigned to Ipilimumab 3mg/kg IV over 90 minutes versus Ipilimumab 3 mg/kg IV over 90 minutes and radiotherapy to one of their measurable lesions, 6 Gy X5 (conformally or by IMRT/IGRT, to maximally spare normal tissue). For patients assigned to the Ipi/RT arm, Ipilimumab treatment starts after radiotherapy, with a dose given on day 4 from the first radiotherapy fraction and repeated on Days 25, 46 and 67. Patients will be re-imaged on Week 12 and evaluated for response (defined as an objective response of another metastatic site outside the radiation field). This response will be evaluated assessing clinical and CT responses in the non-irradiated measurable metastatic sites.

NYU Langone Health

Ipilimumab administered alone Day 4, 25, 46, and 67

Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67.

Arm A: Ipilimumab

Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.

Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67.

Arm B: Ipilimumab and Radiation

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Sylvia Formenti, MD

Study terminated because PI left institution. Data cannot be reported because 2 year data were not collected and were not analyzed.

Response Rates of Ipilimumab Alone and of Ipilimumab With Radiation Therapy and to Estimate the Difference Between Response Rates With Ipilimumab Alone and Ipilimumab With Radiation Therapy

Overall Study

Symptoms and General Pathology

Death

Spartalizumab

LHC165 intratumoral injection given alone

LHC165 intratumoral injection given with PDR001 infusion

LHC165

PDR001

Nehal Parikh, MD

The purpose of this trial was to explore the clinical utility of two investigational agents in patients with advanced cancer.

This was a multi-center, open-label Phase I/Ib study. The primary objectives of the trial were:

* To characterize the safety and tolerability of intratumoral LHC165 in patients with solid tumors as a single agent and in combination with PDR001
* To determine and evaluate the maximum tolerated dose (MTD)/recommended dose (RD) for LHC165 as a single agent and in combination with PDR001

This was a multi-center, open-label Phase I/Ib study. The study consisted of four dose escalation parts and two dose expansion parts testing LHC165 as a single agent or LHC165 in combination with PDR001. The dose escalation parts estimated the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) and were planned to test two different dosing schedules for LHC165 single agent (Group A and B) and LHC165 in combination with PDR001 (Group C and D).

The dose expansion parts of the study were planned to use the MTD/RDE for each the LHC165 single agent (Group E) and LHC165 in combination with PDR001 (Group F), determined in the respective dose escalation parts to assess the activity, safety and tolerability of LHC165 as a single agent or LHC165 in combination with PDR001 in patients with specific types of solid tumors.

The study was terminated due to business reasons. Groups B, D and E were not opened for enrollment.

Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

A Phase I/Ib, Open-label, Multi-center Dose-escalation and Dose-expansion Study of the Safety and Tolerability of Intra-tumorally Administered LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Randomized Trial of Ipilimumab Versus Ipilimumab and Radiotherapy in Metastatic Melanoma	NCT01689974	Metastatic Mela...	Ipilimumab Radiation Thera...	19 Years - 80 Years	NYU Langone Health
Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies	NCT03301896	Solid Tumors	LHC165 PDR001	18 Years -	Novartis

Spots Global Cancer Trial Database for abscopal

Every month we try and update this database with for abscopal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for abscopal

Every month we try and update this database with for abscopal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for abscopal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.