Buscador de ensayos clínicos

Comentarios

For locally advanced rectal cancer. Stage III, no received treatment for rectal cancer (chemotherapy, radiotherapy or surgery) yet. Along with standard of care, the addition of anti PD-1 (nivolumab) must prevent recurrence.

Contactos

Criterios de inclusión

Criterios de inclusión:

Signed written IRB approved informed consent
Edad ≥ 18 años
ECOG PS 0-1
Subjects with histologically confirmed primary (non-recurrent) locally advanced rectal adenocarcinoma
Stage T3-4 N0 or TX N+ according to baseline rectal EUS and PET-CT
Patients who are planned for neoadjuvant chemoradiation and are surgical candidates
No prior chemotherapy, radiotherapy or surgery for rectal cancer
No prior radiotherapy to the pelvis, for any reason
Presence of adequate contraception in fertile patients
Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
Women must not be breastfeeding
Ability to swallow tablets
No previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin

Criterios de exclusión

Criterios de exclusión:

Active autoimmune disease. [Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll]
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Pregnancy or breastfeeding