Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma. A Phase IIA study

Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma. A Phase IIA study - SPARTANA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002563-22-FR

Enrollment

Unknown

Registered

2021-05-19

Start date

2021-09-13

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic anal canal cancer

Interventions

Product Name: spartalizumab Product Code: PDR001 Pharmaceutical Form: Solution for injection INN or Proposed INN: SPARTALIZUMAB CAS Number: 1935694-88-4 Other descriptive name: PDR001 Trade Name: DOC

Eligibility

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this clinical trial is to evaluate the Progression-Free Survival (PFS) rate at 1 year.;Secondary Objective: •the objective response rate •the overall survival •the Progression Free Survival median •the complete response rate •To assess the impact of this combination treatment on patient’s health related quality of life •To assess the patient’s health related quality of life treated by this combination •To evaluate the safety of this combination of treatment •To evaluate the pharmacodynamics of the combination treatment: HPV-specific and telomerase-specific T cell responses before and after treatment in peripheral blood mononuclear cells •To analyse the tumor genotyping for HPV, p53 and PD-1 expression and to study the correlation of these biomarkers with treatment efficacy •To characterize the tumor-infiltrating lymphocytes and PD-L1 expression in tumors •To explore the correlation of both peripheral CD4 anti-telomerase immunity and PD-L1 immunohistochemistry with progression-free survival •To characterize the prognostic value of circulating HPV DNA on oncological outcomes;Primary end point(s):	—

Measure

Time frame

Main Objective: The primary objective of this clinical trial is to evaluate the Progression-Free Survival (PFS) rate at 1 year.;Secondary Objective: •the objective response rate •the overall survival •the Progression Free Survival median •the complete response rate •To assess the impact of this combination treatment on patient’s health related quality of life •To assess the patient’s health related quality of life treated by this combination •To evaluate the safety of this combination of treatment •To evaluate the pharmacodynamics of the combination treatment: HPV-specific and telomerase-specific T cell responses before and after treatment in peripheral blood mononuclear cells •To analyse the tumor genotyping for HPV, p53 and PD-1 expression and to study the correlation of these biomarkers with treatment efficacy •To characterize the tumor-infiltrating lymphocytes and PD-L1 expression in tumors •To explore the correlation of both peripheral CD4 anti-telomerase immunity and PD-L1 immunohistochemistry with progression-free survival •To characterize the prognostic value of circulating HPV DNA on oncological outcomes;Primary end point(s):

—

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026