PREventing Second Cancers With DOSTARlimab
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patient ≥18 years of age at time of informed consent form signature. Note - Patients with childhood first primary cancer (FPC) are eligible.
Patients with prior histologically proven primary solid tumors (any type), AJCC stage I, II or III or IV if M0, eligible to curative treatment. Note - Time between end of treatment for first cancer and randomisation must be <6 months.
Exposure to exogenous risk factor : tobacco (>20YP) ≥ 10 years and still active at time of FPC diagnosis and/or Endogenous risk factors (genetic predisposition including for instance germ line mutations of p53 or BRCA genes, Lynch syndrome, or any mutations of genes known to be associated with higher risk of cancer according to current list from French National Cancer institute or HPV-related FPC.
Availability of FFPE tumor sample from FPC initial diagnosis for histological comparison in case/at time of SPC. Note - Histological report must be sent to the sponsor with archival FFPE tumor block within 14 days after randomisation.
Disqualifiers
Previous treatment with immunotherapy (any types) for cured first primary cancer.
Acute and ongoing toxicities from previous therapy that have not resolved to Grade ≤ 1, except for alopecia, neuropathy and lab values presented in inclusion criteria.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to randomisation or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure.
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to randomisation, or anticipation of need for systemic immunosuppressive medication during study treatment; with the exceptions of intranasal, inhaled, or topical corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
Trial design
Design model
Parallel
Treatments tested in this trial
Dostarlimab
DrugDostarlimab should initiated within 6 months after the end of treatment for FPC.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: DostarlimabExperimental treatment 1 intervention
Group B: No treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of Second Primary Cancer (SPC) in patients who have completed curative treatment for a First Primary Cancer (FPC).
Second primary invasive cancer must be centrally histologically confirmed
Time frame
Up to 3 yearsSecondary outcomes
1
Rate of SPC
Time frame
Up to 3 years2
Time to SPC
Time frame
Up to 3 years3
Event Free survival
Time frame
Up to 3 years4
Overall Survival since randomisation and since SPC
Time frame
Up to 3 yearsOther outcomes
1
Molecular profiles of SPC and immune infiltrate characterisation by WES analysis (tumor samples)
Time frame
From FPC material and in case of SPC (biopsy diagnostic or surgery)2
Immune parameters definition by cytometry analysis (blood samples)
Time frame
At inclusion, 30 days after the last injection and in case of SPC (at diagnostic timing)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Leon Berard
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov