Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SQZ-PBMC-HPV · 1 trial · 1 indication
For SQZ-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)
For SQZ-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)
Proportion of patients with best response of complete response \[CR\] and/or partial response \[PR\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)
Evaluation of the BoR defined as CR, PR, Stable Disease \[SD\], Progressive Disease \[PD\] or Not Evaluable \[NE\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)
Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)
Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)
Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)
Defined as the time from first dose of study treatment to death by any cause. This will be censored at the last date patient is known to be alive if death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)
| Arm | Type | Description |
|---|---|---|
| Part 1 Monotherapy Dose Escalation Phase | EXPERIMENTAL | In Part 1, SQZ-PBMC-HPV as a monotherapy is administered on Day 1 of every 3 week cycles for up to a year. In Cohort 3 (double-priming), SQZ-PBMC-HPV is also administered on Day 2 of Cycle 1. There are at least 3 groups ("Cohorts") in this Phase as follows: * Cohort 1: specified dose SQZ-PBMC-HPV * Cohort 2: specified dose SQZ-PBMC-HPV * Cohort 3: specified dose SQZ-PBMC-HPV double-priming |
| Part 2 Combination Safety Phase | EXPERIMENTAL | In Part 2, SQZ-PBMC-HPV in combination with immune checkpoint inhibitors (1) atezolizumab, (2) ipilimumab, (3) nivolumab, or (4) nivolumab and ipilimumab, is administered every 3 weeks for up to a year except atezolizumab may be given up to 2 years; and ipilimumab will be administered four times (in a timeframe less than a year) if safety allows. There are 4 groups ("Cohorts") in this Phase as follows: * Cohort 4: SQZ-PBMC-HPV RP2D (Recommended Phase 2 Dose) plus atezolizumab * Cohort 5: SQZ-PBMC-HPV RP2D plus ipilimumab * Cohort 6: SQZ-PBMC-HPV RP2D plus nivolumab * Cohort 7: SQZ-PBMC-HPV RP2D plus nivolumab and ipilimumab |
| Part 3 Monotherapy Dose Expansion Phase | EXPERIMENTAL | In Part 3, SQZ-PBMC-HPV is administered at the RP2D to patients enrolled in HPV16+ cancer-type specific cohorts. There are 4 groups ("Cohorts") in this Phase as follows: * Cohort 8: SQZ-PBMC-HPV RP2D in HPV16+ head and neck cancer patients * Cohort 9: SQZ-PBMC-HPV RP2D in HPV16+ cervical cancer patients * Cohort 10: SQZ-PBMC-HPV RP2D in HPV16+ anal cancer patients * Cohort 11: SQZ-PBMC-HPV RP2D in other HPV16+ cancer patients |
| Name | Type | Description |
|---|---|---|
| SQZ-PBMC-HPV | BIOLOGICAL | antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16 |
| Atezolizumab | DRUG | programmed cell death ligand 1 (PD-L1) blocking antibody |
| Ipilimumab | DRUG | cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody |
| Nivolumab | DRUG | programmed cell death 1 (PD-1) blocking antibody |
Key Inclusion Criteria: * Male or female patients ≥18 years of age who are HLA-A\*02+ (performed during screening locally or centrally, or based on documented historic test results) * Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally o...