Activity and safety of peptide-based immunotherapy in an umbrella window of opportunity phase II study in patients with squamous cell carcinoma of the head and neck.

Conditions

squamous cell carcinoma of the head and neck

Brief summary

ELISpot responses will be considered positive when the numbers of IFN-γ secreting cells will be at least two-fold greater than the mean value of the baseline with a minimum of 50 spots (per 2-5 × 105 PBMC) detected

Detailed description

Arm A (IO102 vaccine) : 1) Safety, tolerability of IO102, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0., Arm A (IO102 vaccine) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes and by measuring the serum levels of kynurenin, tryptophan and kynurenin/tryptophan ratio., Arm A (IO102 vaccine) : 3) Objective response rate (ORR), Overall survival (OS), Disease Free-Survival (DFS), Disease Specific Survival (DSS), Arm A (IO102 vaccine) : 4) To investigate the efficacy of IO102 in monotherapy using MRI and DWI-MRI to visualize possible significant tumor modifications, Arm C (IO103 vaccine) : 1) Safety, tolerability of IO103, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0, Arm C (IO103 vaccine) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes, Arm C (IO103 vaccine) : 3) Objective response rate (ORR), Overall survival (OS), Disease Free-Survival (DFS), Disease Specific Survival (DSS), Arm C (IO103 vaccine) : 4) To investigate the efficacy of IO103 in monotherapy using MRI and DWI-MRI to visualize possible significant tumor modifications, Arm D (IO102+IO103 vaccines) : 1) Safety, tolerability of IO102+IO103, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0., Arm D (IO102+IO103 vaccines) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes by measuring the serum levels of kynurenin, tryptophan and kynurenin/tryptophan ratio., Arm D (IO102+IO103 vaccines) : 3) Objective response rate (ORR), Overall survival (OS), Disease Free-Survival (DFS), Disease Specific Survival (DSS), Arm D (IO102+IO103 vaccines) : 4) To investigate the efficacy of IO102+IO103 in monotherapy using MRI and DWI-MRI to visualize possible significant tumor modifications

Related papers

No related papers found yet.

Interventions

DRUGIO103 + Montanide

DRUGIO102 + Montanide

DRUGIO102 + IO103 + Montanide

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ELISpot responses will be considered positive when the numbers of IFN-γ secreting cells will be at least two-fold greater than the mean value of the baseline with a minimum of 50 spots (per 2-5 × 105 PBMC) detected	—

Secondary

Measure	Time frame
Arm A (IO102 vaccine) : 1) Safety, tolerability of IO102, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0., Arm A (IO102 vaccine) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes and by measuring the serum levels of kynurenin, tryptophan and kynurenin/tryptophan ratio., Arm A (IO102 vaccine) : 3) Objective response rate (ORR), Overall survival (OS), Disease Free-Survival (DFS), Disease Specific Survival (DSS), Arm A (IO102 vaccine) : 4) To investigate the efficacy of IO102 in monotherapy using MRI and DWI-MRI to visualize possible significant tumor modifications, Arm C (IO103 vaccine) : 1) Safety, tolerability of IO103, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0, Arm C (IO103 vaccine) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes, Arm C (IO103 vaccine) : 3) Objective response rate (ORR), Overall survival (OS), Diseas	—

Measure

Time frame

Arm A (IO102 vaccine) : 1) Safety, tolerability of IO102, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0., Arm A (IO102 vaccine) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes and by measuring the serum levels of kynurenin, tryptophan and kynurenin/tryptophan ratio., Arm A (IO102 vaccine) : 3) Objective response rate (ORR), Overall survival (OS), Disease Free-Survival (DFS), Disease Specific Survival (DSS), Arm A (IO102 vaccine) : 4) To investigate the efficacy of IO102 in monotherapy using MRI and DWI-MRI to visualize possible significant tumor modifications, Arm C (IO103 vaccine) : 1) Safety, tolerability of IO103, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0, Arm C (IO103 vaccine) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes, Arm C (IO103 vaccine) : 3) Objective response rate (ORR), Overall survival (OS), Diseas

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Countries

Belgium

Outcome results

None listed