Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial



Sponsor:   Ospedale Policlinico San Martino


Sommario: 
      The purpose of this study is to evaluate the efficacy of Durvalumab plus Regorafenib versus
      observation for patients with stage IV colorectal cancer achieving the no evidence of disease
      state.

      The NED state can be achieved in any line of treatment and it is defined as:

        1. R0 resection for surgery,

        2. the complete ablation defect covering the lesion on CT scan for radiofrequency,

        3. the erogation of ≥ 60 Gy for stereotactic radiotherapy,

        4. complete response to antineoplastic treatments on CT scan. In all these cases CEA and CA
           19.9 must be within normal limits at the time of randomization.

      Participants in this study will receive:

      Experimental arm:

      Regorafenib 90 mg d1-21 every 28 days plus Durvalumab 1500 mg every 28 days for 1 year

      Control arm:

      Observation (crossover to Experimental arm is allowed in case of relapse)

      Tumor assessment will be performed every 12 weeks.
    




TIPOLOGIA STUDIO

 
Interventistico



FASE

 
Fase 2




TRATTAMENTO

  
    
  
  • Durvalumab Injection for intravenous use 500 mg vial solution for infusion
  • Regorafenib 30 mg capsules
    • 






OBIETTIVO PRIMARIO


  
  • Misura: Disease Free Survival
  • Tempo: approximately 48 months
  • Descrizione: Disease free survival, defined as the time from the date of randomization to the earliest documented disease relapse (local or distant), death due to any cause or two consecutive increases of CEA above upper limit (time gap no longer than 30 days).




OBIETTIVO SECONDARIO


  
  • Misura: 18 months - Disease Free Survival
  • Tempo: approximately 48 months
  • Descrizione: Disease free survival, defined as the time from the date of randomization to the earliest documented disease relapse (local or distant), death due to any cause or two consecutive increases of CEA above upper limit (time gap no longer than 30 days).
  • Misura: Overall Survival
  • Tempo: approximately 48 months
  • Descrizione: Overall survival, defined as the time from the date of randomization to death due to any cause
  • Misura: Incidence of adverse events
  • Tempo: approximately 48 months
  • Descrizione: An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Toxicity/adverse events are classified according to NCI CTCAE version 5.0.




CRITERI DI ELIGIBILITA'


    
             
  • 
        Criteri di inclusione e esclusione
        
    
        Inclusion Criteria:

          1. ≥ 18 years; ECOG PS 0-1;

          2. Body weight >30 kg;

          3. Histologically confirmed diagnosis of colorectal adenocarcinoma;

          4. Patients must be in NED after completion of any treatments for stage IV CRC, including
             resections, RFA; RT with or without neoadjuvant/adjuvant therapies or CR after
             chemotherapy;

          5. Patients must be randomized within 10 weeks since the achievement of the NED state.
             Those who have also received adjuvant therapy following the locoregional treatment are
             still eligible, provided they are randomized within 4 weeks since the last
             chemotherapy cycle;

          6. NED state ascertained by means of CT scan and/or PET scan and/or MRI scan;

          7. Life expectancy of at least 12 weeks;

          8. CEA within normal limits;

          9. No residual toxicity from previous chemotherapy;

         10. Adequate organ function;

        Exclusion criteria:

          1. MSI/dMMR patients;

          2. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the
             exception of alopecia and vitiligo;

          3. Active or prior documented autoimmune or inflammatory disorders;

          4. Relevant concomitant comorbidities;
      
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: 18 Years

Età Massima: N/A






LUOGO


  
IRCCS Ospedale Policlinico San Martino
Genova, 16132
Contatto:  Alberto Sobrero, MD

      


    
REFERENTE PER INFORMAZIONI

    

      Alberto Sobrero, MD
      +39 010 555 4386
      alberto.sobrero@hsanmartino.it