Trial Outcomes & Findings for Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist (NCT NCT00960752)

Last Updated: 2021-08-13

Results Overview

T-cell response to gp100(g209-2M) +/- MAGE3 measured at 8 weeks using a tetramer/multimer assay measured by flow cytometry. Based on the number of gp100(g209-2M) +/- MAGE3 T-cells measured, categorized as either immune responders or immune non-responders. T-cell response to the gp100(g209-2M) + /- MAGE3 peptide in each participant defined as ≥0.1% gp100(g209-2M) tetramer+ cells in the CD8+ T-cell population or ≥0.1% MAGE3 multimer cells in the CD4+ T-cell population.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-08-13

Participant Flow

47 participants enrolled on study, 1 participant screen failure, 1 participant stopped prematurely due to toxicity.

Participant milestones

Participant milestones
Measure	Group 1: GP100 and MAGE-3 + R848 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.	Group 2: GP100 and MAGE-3 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.	Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
Overall Study STARTED	13	13	19
Overall Study COMPLETED	13	13	17
Overall Study NOT COMPLETED	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: GP100 and MAGE-3 + R848 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.	Group 2: GP100 and MAGE-3 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.	Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
Overall Study Adverse Event	0	0	1
Overall Study Progression	0	0	1

Baseline Characteristics

Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: GP100 and MAGE-3 + R848 n=13 Participants 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.	Group 2: GP100 and MAGE-3 n=13 Participants 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.	Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848 n=19 Participants 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants	9 Participants n=107 Participants	4 Participants n=206 Participants	24 Participants n=7 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	4 Participants n=107 Participants	15 Participants n=206 Participants	21 Participants n=7 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	13 Participants n=7 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	9 Participants n=107 Participants	15 Participants n=206 Participants	32 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=99 Participants	13 Participants n=107 Participants	18 Participants n=206 Participants	43 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants	13 Participants n=107 Participants	19 Participants n=206 Participants	45 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment United States	13 participants n=99 Participants	13 participants n=107 Participants	19 participants n=206 Participants	45 participants n=7 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The original PI is no longer in the institution. Due to the absence of the original PI is no longer in the institution and the data is unavailable. The analysis for the primary outcome measure the comparison of immune responses of vaccine+R848 to vaccine alone is not available. All efforts were made to retrieve data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: The original PI is no longer in the institution. Due to the absence of the original PI is no longer in the institution and the data is not available. The analysis for the secondary outcome measure the composite of Immune Cell Infiltration for pDCs, mDCs, and NK cells in Tumor Biopsy Samples data is unavailable .All efforts were made to retrieve data.

Differences determined in each of these parameters between the pretreatment and post-treatment samples for each of the biopsied lesions for each participant.

Outcome measures

Outcome data not reported

Adverse Events

Group 1: GP100 and MAGE-3 + R848

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Group 2: GP100 and MAGE-3

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: GP100 and MAGE-3 + R848 n=13 participants at risk 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.	Group 2: GP100 and MAGE-3 n=13 participants at risk 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.	Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848 n=19 participants at risk 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
Blood and lymphatic system disorders Platelet Count Decreased	0.00% 0/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	0.00% 0/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	5.3% 1/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks
Vascular disorders Thromboembolic Event	0.00% 0/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	0.00% 0/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	5.3% 1/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks

Other adverse events

Other adverse events
Measure	Group 1: GP100 and MAGE-3 + R848 n=13 participants at risk 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.	Group 2: GP100 and MAGE-3 n=13 participants at risk 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.	Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848 n=19 participants at risk 1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
General disorders Injection Site Reaction	100.0% 13/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	61.5% 8/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	36.8% 7/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks
Skin and subcutaneous tissue disorders Pruritus	84.6% 11/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	69.2% 9/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	47.4% 9/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks
Nervous system disorders Peripheral sensory neuropathy	38.5% 5/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	38.5% 5/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	21.1% 4/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks
Skin and subcutaneous tissue disorders Rash Maculo-Papular	15.4% 2/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	0.00% 0/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	31.6% 6/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks
Musculoskeletal and connective tissue disorders Pain in Extremity	23.1% 3/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	15.4% 2/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	26.3% 5/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks
Infections and infestations Rhinitis infective	23.1% 3/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	15.4% 2/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	10.5% 2/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks
General disorders Chills	0.00% 0/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	0.00% 0/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	31.6% 6/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks
Nervous system disorders Dizziness	30.8% 4/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	0.00% 0/13 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks	15.8% 3/19 • every 2 weeks through Week 4, then every 4 weeks during the vaccination treatment, up to 8 weeks

Additional Information

Michael Davis, PHD., Chair, Melanoma Medical Oncology

UT MD Anderson Cancer Center

Phone: 713-792-3454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place