Trial Outcomes & Findings for Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer (NCT NCT02933944)
NCT ID: NCT02933944
Last Updated: 2022-01-26
Results Overview
Safety of TG02-treatment by assessment of laboratory parameters (routine haematology and biochemistry), vital signs and recording of adverse events
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
From start of study until End of study, which is approximately 4 weeks after surgery and maximum 20 weeks after start of TG02-treatment
Results posted on
2022-01-26
Participant Flow
Participant milestones
| Measure |
TG02-treatment
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. Part II was not conducted.
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|---|---|
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Overall Study
STARTED
|
6
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Overall Study
COMPLETED
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6
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
Baseline characteristics by cohort
| Measure |
TG02-treatment
n=6 Participants
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. Part II was not conducted.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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3 Participants
n=5 Participants
|
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Age, Continuous
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58.0 years
STANDARD_DEVIATION 10.75 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
New Zealand
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1 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
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PRIMARY outcome
Timeframe: From start of study until End of study, which is approximately 4 weeks after surgery and maximum 20 weeks after start of TG02-treatmentSafety of TG02-treatment by assessment of laboratory parameters (routine haematology and biochemistry), vital signs and recording of adverse events
Outcome measures
| Measure |
TG02-treatment
n=6 Participants
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.
TG02-treatment
Pembrolizumab
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|---|---|
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Patients Safety During Study
Number of patients with Treatment Emergent Adverse Events (TEAEs)
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6 Participants
|
|
Patients Safety During Study
Number of patients with Treatment Emergent Adverse Serious Event (TESAE)
|
2 Participants
|
|
Patients Safety During Study
Number of patients with Grade 3 or 4 Treatment Emergent Adverse Event (TEAE)
|
2 Participants
|
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Patients Safety During Study
Number of patients with Treatment Emergent Adverse Event related to any of the study treatments
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3 Participants
|
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Patients Safety During Study
Number of patients with fatal events
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0 Participants
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Patients Safety During Study
Number of patients discontinuing for Adverse Events
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0 Participants
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PRIMARY outcome
Timeframe: 8 weeksNumber of patients with systemic TG02 specific immune response assessed by a Delayed Type Hypersensitivity (DTH) test
Outcome measures
| Measure |
TG02-treatment
n=6 Participants
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.
TG02-treatment
Pembrolizumab
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|---|---|
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Patients' Immune Response Assessed by Delayed Type Hypersensitive (DTH) Test
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4 Participants
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PRIMARY outcome
Timeframe: 8 weeksSystemic immune response assessed as change in presence of TG02 specific T-cells in peripheral blood
Outcome measures
| Measure |
TG02-treatment
n=6 Participants
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.
TG02-treatment
Pembrolizumab
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|---|---|
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Systemic Immune Response: T-cell Response
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3 Participants
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PRIMARY outcome
Timeframe: 8 weeksPopulation: Due to insufficient number of baseline samples, no valid results can be derived i.e. change in number of activated intratumoural lymphocytes from baseline.
Immunological activation in tumour mass by assessing fold changes from baseline of intra-tumoural lymphocytes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Due to the low number of baseline samples, no treatment effect can be concluded.
Number of patients with changes from baseline in immune suppression factors (such as PDL1, Treg and MSDC) from tumour samples collected pre TG02/GMCSF treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening until surgeryOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening until surgeryOutcome measures
Outcome data not reported
Adverse Events
TG02-treatment
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TG02-treatment
n=6 participants at risk
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. Part II was not conducted.
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|---|---|
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Infections and infestations
Urinary tract infection
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
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Injury, poisoning and procedural complications
Anastomotic leak
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
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Other adverse events
| Measure |
TG02-treatment
n=6 participants at risk
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. Part II was not conducted.
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|---|---|
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General disorders
Influenza like illness
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33.3%
2/6 • Number of events 4 • 14 to 20 weeks on study with up to 10 weeks of treatment
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General disorders
Chills
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16.7%
1/6 • Number of events 4 • 14 to 20 weeks on study with up to 10 weeks of treatment
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General disorders
Injection site pain
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
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General disorders
Injection site pruritus
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
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General disorders
Injection site reaction
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16.7%
1/6 • Number of events 2 • 14 to 20 weeks on study with up to 10 weeks of treatment
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General disorders
Pyrexia
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Gastrointestinal disorders
Abdominal pain lower
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Gastrointestinal disorders
Rectal haemorrhage
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16.7%
1/6 • Number of events 2 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Infections and infestations
Laryngitis
|
16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Musculoskeletal and connective tissue disorders
Arthralgia
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33.3%
2/6 • Number of events 2 • 14 to 20 weeks on study with up to 10 weeks of treatment
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Musculoskeletal and connective tissue disorders
Myalgia
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Renal and urinary disorders
Haematuria
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33.3%
2/6 • Number of events 2 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Renal and urinary disorders
Dysuria
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Renal and urinary disorders
Pollakiuria
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
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33.3%
2/6 • Number of events 2 • 14 to 20 weeks on study with up to 10 weeks of treatment
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Skin and subcutaneous tissue disorders
Alopecia
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
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Skin and subcutaneous tissue disorders
Pruritus
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
|
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Blood and lymphatic system disorders
Neutropenia
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
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Nervous system disorders
Headache
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16.7%
1/6 • Number of events 1 • 14 to 20 weeks on study with up to 10 weeks of treatment
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place