Trial · NCT02933944

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

NCT02933944, Phase 1, Terminated, Targovax ASA; results first posted 2022-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02933944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02933944

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT02933944
Status: Terminated
Phases: Phase 1
Enrollment: 6 participants, actual
Lead sponsor: Targovax ASA
Conditions: Rectal Cancer
Interventions: TG02-treatment, Pembrolizumab
First posted: 2016-10-14
Last updated: 2022-01-26
Results first posted: 2022-01-26

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Patients Safety During Study	From start of study until End of study, which is approximately 4 weeks after surgery and maximum 20 weeks after start of TG02-treatment	Safety of TG02-treatment by assessment of laboratory parameters (routine haematology and biochemistry), vital signs and recording of adverse events
Primary	Patients' Immune Response Assessed by Delayed Type Hypersensitive (DTH) Test	8 weeks	Number of patients with systemic TG02 specific immune response assessed by a Delayed Type Hypersensitivity (DTH) test
Primary	Systemic Immune Response: T-cell Response	8 weeks	Systemic immune response assessed as change in presence of TG02 specific T-cells in peripheral blood
Primary	Immunological Activation in Tumour Mass by Assessing Number of Patients With Increased Intra-tumoural Lymphocytes.	8 weeks	Immunological activation in tumour mass by assessing fold changes from baseline of intra-tumoural lymphocytes.
Secondary	Change of Immune Suppression Factors e.g. PD-1 and T-reg From Pre to Post Treatment	8 weeks	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
Secondary	Change in Pathological Responses and Markers of Apoptosis in Tumour Tissue	8 weeks
Secondary	Changes in Standard Uptake Values (SUV) Will be Assessed by FDG PET-CT Images	From screening until surgery
Secondary	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	From screening until surgery

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Patients Safety During Study	From start of study until End of study, which is approximately 4 weeks after surgery and maximum 20 weeks after start of TG02-treatment		Participants	NUMBER
PRIMARY	Patients' Immune Response Assessed by Delayed Type Hypersensitive (DTH) Test	8 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Systemic Immune Response: T-cell Response	8 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Immunological Activation in Tumour Mass by Assessing Number of Patients With Increased Intra-tumoural Lymphocytes.	8 weeks	Due to insufficient number of baseline samples, no valid results can be derived i.e. change in number of activated intratumoural lymphocytes from baseline.
SECONDARY	Change of Immune Suppression Factors e.g. PD-1 and T-reg From Pre to Post Treatment	8 weeks	Due to the low number of baseline samples, no treatment effect can be concluded.
SECONDARY	Change in Pathological Responses and Markers of Apoptosis in Tumour Tissue	8 weeks
SECONDARY	Changes in Standard Uptake Values (SUV) Will be Assessed by FDG PET-CT Images	From screening until surgery
SECONDARY	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	From screening until surgery

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Patients Safety During Study	TG02-treatment	Number of patients with Treatment Emergent Adverse Events (TEAEs)	6	Participants
Patients Safety During Study	TG02-treatment	Number of patients with Treatment Emergent Adverse Serious Event (TESAE)	2	Participants
Patients Safety During Study	TG02-treatment	Number of patients with Grade 3 or 4 Treatment Emergent Adverse Event (TEAE)	2	Participants
Patients Safety During Study	TG02-treatment	Number of patients with Treatment Emergent Adverse Event related to any of the study treatments	3	Participants
Patients Safety During Study	TG02-treatment	Number of patients with fatal events	0	Participants
Patients Safety During Study	TG02-treatment	Number of patients discontinuing for Adverse Events	0	Participants
Patients' Immune Response Assessed by Delayed Type Hypersensitive (DTH) Test	TG02-treatment		4	Participants
Systemic Immune Response: T-cell Response	TG02-treatment		3	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TG02-treatment	6
Overall Study	COMPLETED	TG02-treatment	6
Overall Study	NOT COMPLETED	TG02-treatment	0

Source ClinicalTrials.gov

Adverse events21

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Influenza like illness	General disorders	TG02-treatment	2	6	4
other	Chills	General disorders	TG02-treatment	1	6	4
other	Injection site pain	General disorders	TG02-treatment	1	6	1
other	Injection site pruritus	General disorders	TG02-treatment	1	6	1
other	Injection site reaction	General disorders	TG02-treatment	1	6	2
other	Pyrexia	General disorders	TG02-treatment	1	6	1
other	Abdominal pain lower	Gastrointestinal disorders	TG02-treatment	1	6	1
other	Rectal haemorrhage	Gastrointestinal disorders	TG02-treatment	1	6	2
other	Laryngitis	Infections and infestations	TG02-treatment	1	6	1
other	Arthralgia	Musculoskeletal and connective tissue disorders	TG02-treatment	2	6	2

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TG02-treatment	0	6
Total, other adverse events	TG02-treatment	6	6
Total, serious adverse events	TG02-treatment	2	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02933944

GET https://conductscience.org/api/trials/v1/NCT02933944/events?page=2

API reference For AI assistants