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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

22 Aug 2024 → 29 May 2026

Decision date (initial)

2024-08-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516005-23-00

EudraCT number

2021-002563-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective of this clinical trial is to evaluate the Progression-Free Survival (PFS) rate at 1 year.

Conditions and MedDRA coding

metastatic squamous cell anal carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. 1. Male or female, aged ≥18 years,
2. 2. Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1,
3. 3. Histologically proven metastatic or locally advanced recurrent squamous cell carcinoma of anus (SCCA)Presence of a evaluable lesion on CT-scan/MRI assessed by RECIST v1.1 criteria,
4. 4. Patient eligible to the mDCF regimen
5. 5. No previous systemic (immunotherapy or chemotherapy) treatment.
6. 6. CT scan performed within 30 days prior inclusion,
7. 7. PET scan performed within 30 days prior inclusion
8. 8. Life expectancy ≥12 months,
9. 9. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment: a. Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support. b. White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L). c. Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion. d. Hemoglobin ≥ 9 g/dL (≥ 90 g/L). e. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN with documented liver metastases. f. Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert’s disease ≤ 3 x ULN). g. Serum albumin ≥ 2.8 g/dl. h. Calculated creatinine clearance ≥ 60 mL/min (using the MDRD formula): i. Urine protein/creatinine ratio (UPCR) ≤ 1 g/g
10. 10. Signed and dated informed consent, to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
11. 11. Patient affiliated to or beneficiary of French social security system
12. 12. Ability to comply with the study protocol, in the Investigator’s judgment

Exclusion criteria 30

1. 1. HIV positive patient , CD4 count < 400 cells/mm3 (HIV test mandatory before inclusion)
2. 2. Diagnosis of additional malignancy within 2 years prior to the inclusion with the exception for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy,
3. 3. Any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
4. 4. Current participation in a study of an investigational agent or in the period of exclusion,
5. 5. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment,
6. 6. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible,
7. 7. Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 7.5 months in women and 4.5 months in men from the last treatment administration,
8. 8. Patient under guardianship, curatorship or under the protection of justice.
9. 9. Inability to perform radiotherapy
10. 10. Untreated or symptomatic central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥ 4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥ 2 weeks
11. 11. Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GMCSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents ≤ 2 weeks prior start of study treatment. If erythroid stimulating agents were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained.
12. 12. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment
13. 13. Elevated Cardiac troponin T (cTnT) or cardiac troponin I (cTnI) elevation > 2x ULN
14. 14. Systemic chronic steroid therapy (> 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed. For patients with adrenal insufficiency, replacement dose of prednisone > 10 mg/ day or equivalent are permitted
15. 15. Active, known or suspected autoimmune disease or a documented history of autoimmune disease Note: Patients with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted.
16. 16. Allogenic bone marrow or solid organ transplant
17. 17. History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
18. 18. Pre-existing neuropathy, hearing problem, or cardiorespiratory pathology, which prevent the administration of cisplatin.
19. 19. clinically significant active heart disease or myocardial infarction within 6 months
20. 20. recent or concomitant treatment with brivudine
21. 21. persistent toxicities related to prior treatment of grade greater than 1
22. 22. History or current interstitial lung disease or non-infectious pneumonitis
23. 23. History of major surgery within 28 days before treatment
24. 24. Active infection
25. 25. Active Hepatitis B infection (HBsAg positive)
26. 26. Active hepatitis C (HCV RNA positive)
27. 27. Pregnant or nursing (lactating) women confirmed by a positive hCG laboratory test within 72 hours prior to initiating study treatment. Note: Low levels of hCG may also be considered a tumor marker, therefore if low hCG levels are detected, another blood sample at least 4 days later must be taken to assess the kinetics of the increase and transvaginal ultrasound must be performed to rule out pregnancy.
28. 28. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7.5 months after stopping treatment with Spartalizumab.
29. 29. Complete or partial deficit in dihydropyrimidine dehydrogenase (DPD) activity
30. 30. Active inflammatory bowel disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the Progression Free Survival (PFS) rate at 1 year evaluated by RECIST criteria v1.1. PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire

Sponsor organisation

Centre Hospitalier Regional Universitaire

Address

2 Place Saint Jacques, Cs 51804 Cs 51804

City

Besancon Cedex

Postcode

25030

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire

Contact name

Chargé de projet

Public contact point

Organisation

Centre Hospitalier Regional Universitaire

Contact name

Chef de projet

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications