OncoMatch/Clinical Trials/NCT05855811
PREventing Second Cancers With DOSTARlimab
Is NCT05855811 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Dostarlimab for recurrent cancer.
Treatment: Dostarlimab — PredoSTAR is a multicenter, randomized, open-label phase II study proposed to patients at high risk of SPC and in whom the treatment of the FPC does not include immunotherapy. Dostarlimab treatment will be started within 6 months after the completion of treatment for localized FPC (i.e. after the end of last CT, RT cure or surgery with a wash-out period of 4 weeks before to start Dostarlimab). Eligible patients will be randomized (1:1) to receive: * Arm Dostarlimab : 4 intravenous (IV) injections of dostarlimab, Q3W or * Arm No treatment
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Allowed: TP53 germ line mutation
germ line mutations of p53
Allowed: BRCA1 germ line mutation
germ line mutations of BRCA genes
Allowed: BRCA2 germ line mutation
germ line mutations of BRCA genes
Disease stage
Required: Stage I, II, III, IV IF M0 (AJCC)
AJCC stage I, II or III or IV if M0, eligible to curative treatment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: curative therapy — first primary cancer
eligible to curative treatment. Note - Time between end of treatment for first cancer and randomisation must be <6 months.
Cannot have received: immunotherapy
Previous treatment with immunotherapy (any types) for cured first primary cancer.
Lab requirements
Blood counts
WBC ≥ 2.5 x 10^9/L; Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Lymphocyte count ≥ 0.5 x 10^9/L
Kidney function
Serum creatinine clearance ≥30 mL/min/1.73m2 or serum creatinine ≤1.5 ULN
Liver function
Serum bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert disease); AST, ALT, ALP ≤ 2.5 × ULN
Cardiac function
QTc <450msec (or <480msec for bundle branch block)
Adequate hematologic and end-organ function, defined by the following laboratory test results: WBC ≥ 2.5 x 10^9/L, Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Lymphocyte count ≥ 0.5 x 10^9/L; Serum creatinine clearance ≥30 mL/min/1.73m2 or serum creatinine ≤1.5 ULN; Serum bilirubin ≤ 1.5 × ULN, with the following exception: Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled; AST, ALT and ALP ≤ 2.5 x ULN; QTc <450msec (or <480msec for participants with bundle branch block).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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