Symptoms and General Pathology

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All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Vaccines

Immune Checkpoint Inhibitors

Immunomodulating Agents

Nivolumab

Ipilimumab

Immunoglobulins

Antibodies, Blocking

Antineoplastic Agents, Immunological

In Part 1, SQZ-AAC-HPV as a monotherapy is administered every 3 weeks for up to a year.

There are 3 groups ("Cohorts") in this Phase as follows:

* Cohort 1a: low dose SQZ-AAC-HPV
* Cohort 1b: high dose SQZ-AAC-HPV
* Cohort 1c: higher or lower dose SQZ-AAC-HPV

In Part 2, SQZ-AAC-HPV in combination with immune checkpoint inhibitors (1) ipilimumab, (2) nivolumab, or (3) nivolumab plus ipilimumab is administered every 3 weeks up to a year, but the immune checkpoint inhibitors may be administered up to 2 years. There are 3 groups ("Cohorts") in this Phase as follows:

* Cohort 2a: SQZ-AAC-HPV RP2D (Recommended Phase 2 Dose) plus ipilimumab
* Cohort 2b: SQZ-AAC-HPV RP2D plus nivolumab
* Cohort 2c: SQZ-AAC-HPV RP2D plus nivolumab and ipilimumab

Activating antigen carriers (AACs) cell therapy; therapeutic vaccine engineered from red blood cells manufactured with immunogenic epitopes of HPV16

SQZ-AAC-HPV

Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody

Programmed cell death 1 (PD-1) blocking antibody

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in HLA-A\*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

A Phase 1, Multicenter, Open-Label Study of SQZ-AAC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

For SQZ-AAC-HPV administered as monotherapy, and in combination with immune checkpoint inhibitors (Part 1 and Part 2, respectively)

For SQZ-AAC-HPV as a monotherapy (Part 1)

For SQC-AAC-HPV in combination with immune checkpoint inhibitors (Part 2)

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-AAC-HPV as a monotherapy, in combination with immune checkpoint inhibitors (Part 1, and Part 2, respectively).

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-AAC-HPV as a monotherapy, in combination immune checkpoint inhibitors (Part 1, and Part 2, respectively).

Proportion of patients with best response of complete response \[CR\] and/or partial response \[PR\] as defined by RECIST v1.1 criteria. For SQZ-AAC-HPV as a monotherapy, in combination immune checkpoint inhibitors (Part 1, and Part 2, respectively).

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-AAC-HPV as a monotherapy, in combination with immune checkpoint inhibitors (Part 1, and Part 2, respectively).

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-AAC-HPV as a monotherapy, in combination with immune checkpoint inhibitors (Part 1, and Part 2, respectively).

Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-AAC-HPV as a monotherapy, in combination immune checkpoint inhibitors (Part 1, and Part 2, respectively).

To determine manufacturing feasibility as assessed by batch yield (number of manufacturing runs) (Part 1)

To determine manufacturing feasibility as assessed by number of product failures (Part 1)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors	NCT04892043	Adult Solid Tum...	SQZ-AAC-HPV Ipilimumab Nivolumab	18 Years -	SQZ Biotechnologies
Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors	NCT04892043	Adult Solid Tum...	SQZ-AAC-HPV Ipilimumab Nivolumab	18 Years -	SQZ Biotechnologies

Spots Global Cancer Trial Database for solid tumors cancer