Oncology
Conditions
Brief summary
Phase Ib: To characterize safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Atezolizumab given in combination with 6TG and 6MP, Phase II: To evaluate the anti-tumor activity in terms of objective response rate in patients treated with Atezolizumab, 6TG and 6MP
Detailed description
To evaluate the efficacy with respect to Progression Free Survival, Overall Survival, and Duration of Response, Characterization of immune cells in tumor and peripheral blood prior to, during treatment and upon progression, Characterization of the tumor mutational and neoantigen landscape prior to, during treatment, and upon progression using WGS and RNAseq on serial biopsies, Characterization of the tumor mutation and neoantigen landscape in circulating tumor cells (ctDNA) prior to, during treatment, and upon progression, HLA typing determined by germline WGS as predictor of efficacy, Tumor gene expression determined by RNAseq signatures as predictor of efficacy, Sequential shallow whole exome ctDNA sequencing to monitor effect, Gene variants in PD-1 and CTLA-4 as predictors of response to treatment, Correlations between plasma DNA-TG levels and anti-tumor-activity
Interventions
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase Ib: To characterize safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Atezolizumab given in combination with 6TG and 6MP, Phase II: To evaluate the anti-tumor activity in terms of objective response rate in patients treated with Atezolizumab, 6TG and 6MP | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy with respect to Progression Free Survival, Overall Survival, and Duration of Response, Characterization of immune cells in tumor and peripheral blood prior to, during treatment and upon progression, Characterization of the tumor mutational and neoantigen landscape prior to, during treatment, and upon progression using WGS and RNAseq on serial biopsies, Characterization of the tumor mutation and neoantigen landscape in circulating tumor cells (ctDNA) prior to, during treatment, and upon progression, HLA typing determined by germline WGS as predictor of efficacy, Tumor gene expression determined by RNAseq signatures as predictor of efficacy, Sequential shallow whole exome ctDNA sequencing to monitor effect, Gene variants in PD-1 and CTLA-4 as predictors of response to treatment, Correlations between plasma DNA-TG levels and anti-tumor-activity | — |
Countries
Denmark
Outcome results
None listed