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Recurrent CancerPhase 2PREDOSTARNCT05855811

PREventing Second Cancers With DOSTARlimab

A Phase 2 study testing Dostarlimab in people with Recurrent Cancer and Primary Cancer, run by Centre Leon Berard at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Cancer, Primary Cancer, Second Cancer
What is being tested?
Dostarlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
5 sitesFrance
Study dates
26 Jul 2023to 26 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Patients with at least one risk factor for second primary cancer (SPC) including:
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or .
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  • Adequate hematologic and end-organ function, defined by the following laboratory test results:
  • WBC ≥ 2.5 x 109/L,
  • Hemoglobin ≥ 9.0 g/dL. Patients may be transfused (> 2 weeks before randomisation) to meet this criterion,
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without granulocyte colony-stimulating factor support within 2 weeks before randomisation,
  • Platelets ≥ 100 x 109/L,
  • Lymphocyte count ≥ 0.5 x 109/L;
  • Serum creatinine clearance ≥30 mL/min/1.73m2 (MDRD or CKD-EPI formula - See Appendix) or serum creatinine ≤1.5 ULN
  • Serum bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), with the following exception: Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled;
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 x ULN;
  • Prothrombin time/INR ≤ 1.5, or, if patient is receiving therapeutic anticoagulation, prothrombin time/INR < 3.0
  • aPTT ≤ ULN OR, if patient is receiving therapeutic anticoagulation, aPTT must be < 1.5 ULN. Note: Patient receiving therapeutic anticoagulation must be on stable dose.
  • Proteinuria by urine dipstick < 2+ or 24-hour proteinuria ≤ 1.0 g.
  • Corrected QT interval (QTc) <450msec (or QTc <480msec for participants with bundle branch block).
  • Women patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy and agrees to use adequate contraception for up to 6 months after the final dose of dostarlimab.
  • Fertile men must agree to use an effective method of contraception during the study and for up to 6 months after the last dose of dostarlimab.
  • Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.
  • Patients must be covered by a medical insurance in country where applicable.

Who cannot join

  • 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.
  • Systemic immunostimulatory agents (including, but not limited to, interferons and IL-2) are prohibited within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomisation.
  • Oral or IV antibiotics within 14 days of randomisation.
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  • History of severe allergic or other hypersensitivity reactions to:
  • chimeric or humanized antibodies or fusion proteins,
  • biopharmaceuticals produced in Chinese hamster ovary cells, or
  • any component of the dostarlimab formulation
  • Concurrent treatment with any approved or investigational anti-cancer treatment or participation in another clinical trial with therapeutic intent. Note - Hormonotherapy as part of standard of care is allowed.
  • History of autoimmune disease including (see Appendix 18.5 for a more comprehensive list of pre-existing autoimmune diseases and immune deficiencies and exceptions in the protocol.
  • Infectious diseases:
  • active infection requiring IV antibiotics,
  • severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,
  • active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening),
  • active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,
  • HIV infection,
  • active tuberculosis,
  • influenza vaccination should be given during influenza season. Patients must not receive live attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to randomisation or at any time during the study.
  • Significant cardiovascular disease: see details in the protocol.
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan.
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome).
  • Patient with FPC known to be at high risk of relapse defined as ≥ 70% relapse from FPC within 2 years.
  • Patient patients who are solid organ recipients.
  • Patient with primary cancer of unknown origin (CUP).
  • Pregnant or lactating women

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-Yves BLAY, MD, PhD contact

4 78 78 51 26 ext. +33

jean-yves.blay@lyon.unicancer.fr

5 sites in 1 country

France5 sites, 5 recruiting

  • Centre François Baclesse

    Caen

    Zoé NEVIERE, z.neviere@baclesse.unicancer.fr

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Xavier DURANDO, xavier.durando@clermont.unicancer.fr

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Jean-Yves BLAY, MD,PhD, 4 78 78 51 26 ext. +33, jean-yves.blay@lyon.unicancer.fr

    Jean-Yves BLAY, MD,PhD

    Recruiting

  • Institut Claudius Regaud

    Toulouse

    Victor SARRADIN, sarradin.victor@iuct-oncopole.fr

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Thomas PUDLARZ, thomas.pudlarz@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: A Multicenter, Open-label, Randomized Phase II Study Aiming to Assess the Clinical Impact of Dostarlimab on Occurrence of Second Primary Cancer in Patients With Cured Primary Cancer

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
Being tested
Dostarlimab
Medical subject headings
Recurrence, Neoplasms, Neoplasms, Second Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DostarlimabDrug

    Dostarlimab should initiated within 6 months after the end of treatment for FPC.

Study groups in NCT05855811
Study groupRoleWhat they receive
DostarlimabExperimental4 intravenous injections maximum of dostarlimab, 500mg, every 3 weeks
Receives: Drug: Dostarlimab
No treatmentNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 3 years

Secondary outcomes (6)

  1. Rate of SPC

    Measured: Up to 3 years

  2. Time to SPC

    Measured: Up to 3 years

  3. Event Free survival

    Measured: Up to 3 years

  4. Overall Survival since randomisation and since SPC

    Measured: Up to 3 years

  5. Recurrence of FPC.

    Relapse of first cancer rate

    Measured: Up to 3 years

  6. Safety profile

    Only for Arm A : any AEs graded using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.

    Measured: from the date of first intake of study drug until 90 days after study drug discontinuation or at time of initiation of a new anti-cancer treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start26 Jul 2023
  3. Primary completion26 Jul 2028 (estimated)
  4. Study completion26 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Analysis will be performed according the ITT principe and will include all randomized patients. Incidence of events by arm will be compared assuming a Poisson distribution. Cumulative incidence curves against time will we compared between treatment arms. Follow-up of each patient will be calculated from randomisation to death or last follow-up for alive patients.
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05855811
Sponsor's protocol ID
ET22-215
Acronym
PREDOSTAR
Status last verified
Jul 2024
First submitted
4 May 2023
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab in people with Recurrent Cancer and Primary Cancer, run by Centre Leon Berard at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean-Yves BLAY, MD, PhD (4 78 78 51 26 ext. +33, jean-yves.blay@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Second Primary Cancer (SPC) in patients who have completed curative treatment for a First Primary Cancer (FPC). (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05855811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.

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