Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Recurrent Oncogenic RAS Exon 2 Mutant Rectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02933944|
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : December 19, 2017
The purpose of this study is to determine safety and anti-tumor immune activation generated by TG02 and Granulocyte macrophage colony stimulating factor (GM-CSF), first as monotherapy (Part I), thereafter in combination with the checkpoint inhibitor pembrolizumab (Part II), in patients with locally recurrent rectal cancer scheduled to have surgery.
Part I and Part II will include approximately 10 patients each. Part I and Part II are separate and independent sequential components of the study. Patients will only be able to participate in either the Part I cohort or Part II cohort.
Main objective of the study is to investigate safety and immune response after TG02-treatment.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Biological: TG02-treatment Drug: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Non-Randomised Open-Label Phase Ib Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Recurrent Oncogenic RAS Exon 2 Mutant Rectal Cancer|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2018|
Part I: The TG02-treatment consists of an intradermal injection of GM-CSF followed by an injection of TG02. The GM-CSF is to be given 15-30 minutes before TG02. TG02-treatment will be administered on Days 1, 8, 15, 22 and 36. If surgery after week 10, TG02-treatment will also be given at week 10 (Day 64).
Part II: TG02-treatment will be given as described under Part I. In addition pembrolizumab will be administered.
- Safety of TG02-treatment by assessment of laboratory parameters (routine haematology and biochemistry), vital signs and recording of adverse events [ Time Frame: From start of study until End of study, which is approximately 4 weeks after surgery and maximum 20 weeks after start of TG02-treatment ]
- Number of patients with systemic TG02 specific immune response assessed by a Delayed Type Hypersensitivity (DTH) test. [ Time Frame: 8 weeks ]
- Systemic immune response assessed as change in presence of TG02 specific T-cells in peripheral blood [ Time Frame: 8 weeks ]
- Immunological activation in tumour mass by assessing number of patients with increased intra-tumoural lymphocytes. [ Time Frame: 8 weeks ]
- Change of immune suppression factors e.g. PD-1 and T-reg from pre to post treatment [ Time Frame: 8 weeks ]
- Change in pathological responses and markers of apoptosis in tumour tissue [ Time Frame: 8 weeks ]
- Changes in standard uptake values (SUV) will be assessed by FDG PET-CT images [ Time Frame: From screening until surgery ]
- Changes in the tumour marker Carcinoembryonic Antigen (CEA) throughout treatment will be assessed by analysis of blood samples to follow the evolution of disease under treatment [ Time Frame: From screening until surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933944
|Contact: Karianne Risberg Handeland, PhD||+47 900 30 firstname.lastname@example.org|
|Contact: Magnus Jäderberg, MDemail@example.com|
|Royal Brisbane & Women's Hospital (RBWH)||Recruiting|
|Contact: Matthew Burge, MD|
|Peter MacCallum Cancer Centre||Recruiting|
|Contact: Michael Michael, MD|
|Chris O'Brien Lifehouse||Recruiting|
|Contact: Lisa Horvath, MD|
|Auckland City Hospital||Recruiting|
|Auckland, New Zealand|
|Contact: Sanjeev Deva, MD|
|Christchurch, New Zealand|
|Contact: Dean Harris, MD|