Actively Recruiting
PREventing Second Cancers With DOSTARlimab
Led by Centre Leon Berard · Updated on 2024-07-15
400
Participants Needed
5
Research Sites
295 weeks
Total Duration
On this page
Sponsors
C
Centre Leon Berard
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
PREventing Second Cancers With DOSTARlimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient 18 years of age or older at time of informed consent
- Histologically proven primary solid tumor (any type), AJCC stage I, II or III, or stage IV if M0, treated with curative intent
- Completed treatment for first primary cancer within less than 6 months before randomization
- At least one risk factor for second primary cancer, such as heavy tobacco use, genetic predisposition, Lynch syndrome, or HPV-related first primary cancer
- Availability of tumor tissue sample from initial diagnosis
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function as defined by laboratory criteria
- Corrected QT interval less than 450 msec (or less than 480 msec with bundle branch block)
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and for 6 months after treatment
- Fertile men must agree to use effective contraception during and for 6 months after treatment
- Ability and willingness to comply with study procedures
- Medical insurance coverage where applicable
You will not qualify if you...
- Previous immunotherapy treatment for first primary cancer
- Unresolved toxicities from prior therapy greater than Grade 1 (except alopecia, neuropathy, and specified lab abnormalities)
- Major surgery or significant injury within 28 days before randomization, or abdominal surgery/intervention within 60 days before randomization
- Use of systemic immunosuppressive medication within 2 weeks before randomization, except certain corticosteroids at low doses
- Use of systemic immunostimulatory agents within 4 weeks before randomization
- Use of oral or IV antibiotics within 14 days before randomization
- History of severe allergic reactions to antibodies or components of dostarlimab
- Current treatment with other anticancer therapies or participation in another therapeutic clinical trial (hormonotherapy allowed)
- History of autoimmune disease as specified in protocol
- Active infections requiring IV antibiotics or severe infections within 4 weeks before randomization
- Active hepatitis B or active hepatitis C infection
- HIV infection, active tuberculosis
- Receipt of live attenuated influenza vaccine within 4 weeks before randomization or during study
- Significant cardiovascular disease as detailed in protocol
- History or evidence of certain lung diseases or active pneumonitis
- Uncontrolled significant concomitant diseases affecting compliance or interpretation
- High risk of relapse from first primary cancer (≥ 70% relapse within 2 years)
- Solid organ transplant recipients
- Primary cancer of unknown origin
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Centre François Baclesse
Caen, France
Actively Recruiting
2
Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
3
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
4
Institut Claudius Regaud
Toulouse, France
Actively Recruiting
5
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
J
Jean-Yves BLAY, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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