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

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Ipilimumab

Immunoglobulins

Peginterferon alfa-2b

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antiviral Agents

Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).

Sylatron - Once per week for 12 weeks, given as an injection under the skin.

Sylatron

Yervoy - Once every 3 weeks for 12 weeks (4 times total), given over a 90-minute intravenous infusion (through the vein).

Yervoy

Andrew Brohl, M.D., Ph.D.

The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the patient's blood that recognize their own tissues, known as "autoimmune" antibodies. Investigators also want to find out how likely it is that their tumor will shrink.

Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma

A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma

Number of participants who developed a positive result during treatment for one or more antibodies of a previously negative screen.

This study was not designed to statistically test the efficacy of treatment, and no inferential analyses will be performed. Investigators planned to look for evidence of serologic and clinical autoimmunity.

MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).

MTD of Ipilimumab (Yervoy) combined with peginterferon alfa-2b (Sylatron). To assess the safety, toxicities and tolerability of a regimen of 3 μg/kg weekly Sylatron with concurrent induction Yervoy at 3 mg/kg, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination.

Overall Response: Complete Response (CR) + Partial Response (PR) by immune-related response criteria (irRC). Immune Related CR (irCR): Complete disappearance of all lesions (whether measurable or not, and no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented. Immure Related PR (irPR): decrease in tumor burden \>50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later.

Immune Related Progressive Disease (irPD): increase in tumor burden \>25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later.

OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Percentage of participants with treatment related AEs, Grade 3 to 5. All adverse events, regardless of causality are also reported in the Serious Adverse Event/Other Adverse Event reporting area.

Merck Sharp & Dohme LLC

H. Lee Moffitt Cancer Center and Research Institute

Yervoy With Sylatron

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

All evaluable participants will be those who completed treatment per study criteria.

Dr. Andrew Brohl

Maximum Tolerated Dose (MTD) of Sylatron

Maximum Tolerated Dose (MTD) of Ipilimumab

Complete Response

Partial Response

Number of Participants With Overall Response (OR)

Progression Free Survival (PFS)

Overall Survival (OS)

Treatment Related Adverse Events (AEs) - Grade 3 to 5

Count of Participants Developing Positive Autoantibody Screen

Overall Study

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Bile Duct Cancer

Pembrolizumab

Immunomodulating Agents

Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.

Pembrolizumab will be administered intravenously.

Sylatron will be administered subcutaneously.

Aiwu R. He, MD PhD

This is an open-label, single-arm, multicenter Phase II safety and efficacy study of combination therapy with pembrolizumab and Sylatron (Peginterferon alpha-2b) in patients with advanced cholangiocarcinoma who have progressed on or cannot tolerate frontline chemotherapy.

Pembrolizumab and Sylatron Administration:

Pembrolizumab has been evaluated at 2 mg/kg every 3 weeks (Q3W), 10 mg/kg Q3W, or 10 mg/kg Q2W in multiple previous studies for different types of cancer, the response rate at higher dose level seems not improved compared to that of lower dose level. With concerns of increased toxicities from the combination pembrolizumab and sylatron therapy, the pembrolizumab dose is selected to be 200mg administered every three weeks. The approved dose of sylatron for melanoma is induction treatment at 6 μg/kg/week for 8 doses followed by 5 year of maintenance treatment at 3 μg/kg/week for up to 5 years. The approved dose of sylatron for chronic hepatitis C infection in combination with ribavirin is 1.5μg/kg weekly for 24 to 48 weeks.

Each cycle = 21 days or 3 weeks. Based on the approved dosage of sylatron, we decided to treat patients at 200mcg weekly up to 12 weeks (3 weeks as single agent, and 9 weeks in combination of pembrolizumab). Sylatron will start Cycle 1 Day 1 and continue on a weekly basis. We have prepared to reduce the dose of sylatron to 120mcg weekly, or 60mcg weekly if patients experience unacceptable toxicities at the higher dose level of sylatron.

Pembrolizumab will be administered intravenously as a 30 minute infusion at a dose of 200 mg every 3 weeks starting Week 4. Pembrolizumab will start Cycle 2 Day 1 and continue every 3 weeks. All trial treatments will be administered on an outpatient basis.

Sites should make every effort to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).

With concerns about toxicity while using long-term sylatron, if no additional benefit is seen beyond 12 weeks of treatment on top of that expected from pembrolizumab alone, patients will discontinue sylatron treatment after they have received 12 weeks of this therapy (3 weeks as single agent and 9 weeks in combination with pembrolizumab). Pembrolizumab should be continued in the absence of unacceptable toxicity (based on CTCAE v4) until disease progression-based on RECIST 1.1. In patients who had responded to the combination therapy, when patient shows disease progression while on single agent pembrolizumab treatment, Sylatron may be resumed at the discretion of the site investigator after discussion with the sponsor-investigator.

Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron

A Phase II Multi-center Study Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and Sylatron (Peginterferon Alfa-2b) HCRN:GI16-263

Defined as the proportion of subjects who achieve the best response (CR and PR) determined by RECIST1.1

Defined as time from start of the treatment till the patient's disease progression or death from any cause (those for whom event of progression or death not observed will be censored).

Defined as time from start of the treatment till the patient's death from any cause (patient who are still alive at the end of the study will be censored).

the sum of complete response (CR) + confirmed partial response (PR) and will be determined as per irRC.

the combination of Sylatron and pembrolizumab as assessed by CTCAE v4

Roswell Park Cancer Institute

The Cleveland Clinic

Georgetown University

Hoosier Cancer Research Network

Aiwu Ruth He, MD

Sponsor-Investigator

Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.

Pembrolizumab: Pembrolizumab will be administered intravenously.

Sylatron: Sylatron will be administered subcutaneously.

Pembrolizumab and Sylatron

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Extrahepatic

Gallbladder

Hilum

Intrahepatic

Disease Subtype

This study was terminated by the funder due to the discontinuation of Sylatron.

Clinicaltrials.gov Results Coordinator

No data was collected or analyzed for this objective due to the early termination of the study by the funder.

Asses Objective Response Rate (ORR) of All Patients Receiving Pembrolizumab and Sylatron Combination Therapy

Assess Progression Free Survival (PFS) of Patients Receiving Pembrolizumab and Sylatron

Asses Overall Survival (OS) of Patients Receiving Pembrolizumab and Sylatron

Assess Objective Response Rate (ORR)

Assess Adverse Events, Serious Adverse Events and Serious Adverse Events Leading to Discontinuation of the Treatment (Death) of Combined Pembrolizumab and Sylatron Therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma	NCT01496807	Melanoma	Sylatron Yervoy	16 Years -	H. Lee Moffitt Cancer Center and Research Institute
Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron	NCT02982720	Advanced Cholan...	Pembrolizumab Sylatron	18 Years -	Hoosier Cancer Research Network

Spots Global Cancer Trial Database for sylatron

Every month we try and update this database with for sylatron 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 sylatron

Every month we try and update this database with for sylatron 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 sylatron 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.