Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Amino Acids

Vitamins

Carboplatin

Pemetrexed

Atezolizumab

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Arginine

Folinic Acid

Folate

Vitamin B9

Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 9mg/m2

Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 18mg/m2

Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 36mg/m2

Administered at a fixed dose of 1200 mg (equivalent to an average body weight-based dose of 15mg/kg) by intravenous (IV) infusion every 3 weeks (21 days).

Administered at a fixed dose of 500mg/m2 by IV infusion every 3 weeks.

Administered at a fixed dose of AUC5 by IV infusion every 3 weeks.

Administered by intramuscular (IM) injection to patients once weekly.

ADI PEG20

Peter Szlosarek

iTRAP is an open-label, multi-centre, dose escalation study of ADI PEG20 in combination with atezolizumab, pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung carcinoma (NSCLC) - stage IIIB/IV.

iTRAP is an open-label, multi-centre, dose escalation study of ADI PEG20 in combination with atezolizumab, pemetrexed and carboplatin in patients with advanced non-squamous NSCLC (stage IIIB/IV). Patients will initially receive 4 cycles of ADI PEG20 in combination with atezolizumab, pemetrexed and carboplatin unless there is documented disease progression or unacceptable toxicities. On completion of 4 cycles and in the absence of disease progression requiring other therapeutic interventions, patients may receive additional cycles of ADI PEG20 and/or atezolizumab and/or pemetrexed for up to a maximum of 2 years at the discretion of the treating physician.

Dose escalation will occur using a 3 + 3 design. The trial will start at dose level 1, which represents 100% of the recommended dose of carboplatin (AUC5) and pemetrexed (500mg/m2) when given as a combination, 100% of the atezolizumab recommended dose (1200mg) and 50% of the recommended single agent dose of ADI PEG20 (18mg/m2). ADI PEG20 doses will be increased according to pre-planned dose escalations.

If the maximum tolerated dose (MTD) is reached with the first 6 patients, up to an additional 6 patients will be enrolled at the MTD. The MTD is defined as the dose level below that at which 2/3 or ≥3/6 patients experience a dose limiting toxicity (DLT).

The maximum administered dose (MAD) may also equal the MTD if dose escalation is stopped before two DLTs are observed at a given dose level due to the expectation that higher dose levels would be too toxic to administer to patients or the maximum planned dose level has been achieved.

The MTD will be determined following review of all the relevant toxicity data by the Safety Review Committee (SRC).

If dose level 1 equals the MAD then dose level -1 may be investigated with a 50% reduction in ADI PEG20 (9mg/m2) along with atezolizumab 1200mg, carboplatin AUC5, and pemetrexed 500mg/m2.

Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin

Phase I Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin (ADIAtezoPemCarbo) (iTRAP Study)

Protocol defined haematological events attributed as possibly, probably or definitely related to the study treatment.

Polaris Group

Hoffmann-La Roche

Queen Mary University of London

Skin and Connective Tissue Diseases

Eye Diseases

Rare Diseases

Melanoma

Uveal Neoplasms

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

Eye Neoplasms

Uveal Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Immunomodulating Agents

Nivolumab

Ipilimumab

ADI-PEG 20 will be administered at a dose of 36mg/m2 intramuscularly once a week.

Nivolumab 240mg + Ipilimumab 1mg/kg for up to 8 total doses of ipilimumab. One ipilimumab has completed, nivolumab 480mg will be given every 4 weeks.

Ipilimumab 1mg/kg with Nivolumab 240mg for up to 8 total doses of ipilimumab. The first four doses of ipilimumab will be scheduled once every 3 weeks. The 5th-8th doses of ipilimumab will be scheduled once every 6 weeks with nivoumab 240mg every 3 weeks.

Alexander Shoushtari, MD

This study is measuring the safety of the study drug, ADI-PEG 20, combined with immunotherapy drugs nivolumab and ipilimumab in treating patients with advanced uveal melanoma.

Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma

Pilot Study Combining Arginine Depletion and Checkpoint Inhibition in Uveal Melanomas

• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Memorial Sloan Kettering Cancer Center

Nutritional and Metabolic Diseases

Diseases and Abnormalities at or Before Birth

Sarcoma

Starvation

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Ifosfamide

Isophosphamide mustard

Mesna

Antineoplastic Agents, Alkylating

Alkylating Agents

Protective Agents

Patients will receive ADI-PEG 20 on Day -7 of Cycle 1 and Days 1, 8, and 15 of each of three 21-day cycles, and ifosfamide per dose escalation/de-escalation schedule on days 1 through 5 of each cycle. Mesna will be given on days 1 through 5 with ifosfamide as supportive care. Patients will also receive radiotherapy (XRT) starting on Week 4.

Patients will receive ADI-PEG 20 on Day -7 of Cycle 1 and Days 1, 8, and 15 of each of three 21-day cycles, and ifosfamide per the RP2D determined in Phase I of the study on days 1 through 5 of each cycle. Mesna will be given on days 1 through 5 with ifosfamide as supportive care. Patients will also receive radiotherapy (XRT) starting on Week 4.

ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m\^2 via intramuscular injection into either the deltoid or gluteal muscle.

Ifosfamide will be administered intravenously per package insert and institutional practice on Days 1 through 5 of all 3 cycles.

Radiotherapy will begin on C2D1 and will continue as per institutional practice.

Radiotherapy

Mesna will be administered for supportive care either intravenously or by mouth per package insert and institutional practice on Days 1 through 5 of all 3 cycles.

Mia Weiss, M.D.

Brian Van Tine, M.D., Ph.D.

Angela Hirbe, M.D., Ph.D.

Douglas Adkins, M.D.

Stephanie Perkins, M.D.

Anthony J Apicelli, M.D., Ph.D.

Chongliang (Jason) Luo, Ph.D.

Sasha Haarberg, Pharm.D., BCOP

Heather Benedict Hamilton, M.S.

In this study, patients with soft tissue sarcoma (STS) will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy. In phase I of the study, up to 5 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy.

Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma

A Phase I/II Trial of Neoadjuvant ADI-PEG 20 in Combination With Ifosfamide and Radiotherapy in Soft Tissue Sarcoma (STS)

An adverse event is considered serious if, in the view of the investigator, it results in any of the following:

* Death
* A life threatening adverse event
* Inpatient hospitalization or prolongation of existing hospitalization
* A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
* A congenital anomaly/birth defect
* Any other important medical event that does not fit the criteria above but, based upon appropriate medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above

The MTD is defined as the highest dose level at which no more than 1 out of 6 patients experienced DLT at the end of Cycle 2. Dose escalations will proceed until the MTD has been reached or until Dose Level 3, and this dose level will then be defined as the Recommended Phase 2 Dose (RP2D).

Defined as the proportion of patients with a necrosis in the final surgical specimen.

Defined as the proportion of patients with a pCR confirmed in the final surgical specimen.

Defined as the proportion of patients with a local failure, which is either local tumor recurrence or local tumor progression.

Defined as the time from start of treatment to time of recurrence or death, whichever occurs first.

Defined as the time from start of treatment to death from any cause.

Washington University School of Medicine

Leiomyosarcoma

Gemcitabine

Docetaxel

ADI-PEG 20: 36 mg/m2 on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 600 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 60 mg/m2 on day 8 of each 21-day cycle

Placebo: matched PBO on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 900 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 75 mg/m2 on day 8 of each 21-day cycle

Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)

Placebo

Mirla Langlois

Stephanie V Rumund

Breelyn Wilky, MD

Gina D'Amato, MD

Mihaela Druta, MD

Seth Pollack, MD

Samantha Armstrong, MD

John Rieth, MD

Rashmi Chug, MD

Brian Van Tine, MD

Juneko Grilley-Olson, MD

Paul Savage, MD

Ankit Mangla, MD

David Liebner, MD

Lee Hartner, MD

Albiruni Razak, MB BCh

Ramy Saleh, MD

Wei-Wu (Tom) Chen, MD

Chueh-Chuan Yen

John S Bomalaski

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial

Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 Trial

The primary objective is to compare the primary endpoint of PFS in subjects treated with the arginine degrading enzyme ADI-PEG 20 plus Gem and Doc (ADIGemDoc) or PBO plus Gem and Doc (PBOGemDoc) in the 2nd or 3rd line setting using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by blinded independent central review committee (BICR)

The secondary objectives are to compare ADIGemDoc versus PBOGemDoc with respect to:

Objective response rate (ORR) (complete response \[CR\] + partial response \[PR\]) The secondary endpoint of ORR will be assessed by BICR using RECIST 1.1 and tested using a CMH test stratified by the stratification factors used during the randomization based on the ITT population.

The secondary objectives are to compare ADIGemDoc versus PBOGemDoc with respect to:

OS

The secondary endpoint of OS will be tested using a log-rank test stratified by the stratification factors used during the randomization based on the ITT population. A stratified Cox model will be used to estimate HR and 95% CI, and KM curves will be used to estimate OS median and 95% CI.

All clinically significant abnormalities and deteriorations will be followed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE V5).

Pembrolizumab

Antibodies

Immunoglobulins

Antibodies, Blocking

This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks.

ADI is a recombinant protein cloned from M. hominis and produced in E. coli, and conjugated with PEG of 20,000 mw. Thus ADI-PEG 20 is an arginine degrading enzyme, ADI, coupled to PEG.

Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.

This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks. Assessment of safety and tolerability of drug combination

This is an open-label, phase 1b trial of ADI-PEG 20 in combination with pembrolizumab in subjects with advanced cancers. Dose escalation will occur using a 3 + 3 + 3 design.

The first subject in a dose escalation cohort must have had treatment with ADI-PEG 20 + pembrolizumab with a week of follow up) before the next 2 subjects are enrolled. Thus subjects 2 and 3 may be enrolled on day 8 if there is no dose limiting toxicity (DLT) in subject 1. No additional delay is required between treating subjects 4 to 6 or 7 to 9 in an expanded cohort. Before proceeding to the next cohort dose level, the first 3 eligible subjects in each cohort will have received at least 21 days of treatment (i.e. at least 2 of the expected 3 doses of ADI-PEG 20 + one dose of pembrolizumab).

Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Number of participants with treatment-related adverse events and severity this is graded by CTCAE and MedDRA for Coding

Progression Free Survival determined by RECIST 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin	NCT03498222	Carcinoma, Non-...	Atezolizumab Pemetrexed Carboplatin ADI PEG20	18 Years -	Queen Mary University of London
Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma	NCT03922880	Uveal Melanoma	ADI PEG20 Nivolumab Ipilimumab	18 Years -	Memorial Sloan Kettering Cancer Center
Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma	NCT05813327	Soft Tissue Sar... Sts Sarcoma,Soft Ti...	ADI PEG20 Ifosfamide Radiotherapy Mesna	18 Years -	Washington University School of Medicine
Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin	NCT03498222	Carcinoma, Non-...	Atezolizumab Pemetrexed Carboplatin ADI PEG20	18 Years -	Queen Mary University of London
Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma	NCT03922880	Uveal Melanoma	ADI PEG20 Nivolumab Ipilimumab	18 Years -	Memorial Sloan Kettering Cancer Center
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)	NCT05712694	Soft Tissue Sar...	ADI PEG20 Placebo	18 Years - 99 Years	Polaris Group
Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers	NCT03254732	Advanced Solid ...	ADI PEG20 Pembrolizumab	18 Years -	Polaris Group

Spots Global Cancer Trial Database for adi peg20

Every month we try and update this database with for adi peg20 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 adi peg20

Every month we try and update this database with for adi peg20 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 adi peg20 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.