A Phase I Dose Escalation Study of Selinexor Plus Nivolumab and Ipilimumab in Advanced/Metastatic… (NCT04850755) | Clinical Trial Compass
CompletedPhase 1
A Phase I Dose Escalation Study of Selinexor Plus Nivolumab and Ipilimumab in Advanced/Metastatic Solid Malignancies
Singapore11 participantsStarted 2021-03-08
Plain-language summary
This is a single-centre, phase 1a (dose escalation) and 1b (dose expansion) study to evaluate the safety and tolerability of oral Selinexor in combination with nivolumab and ipilimumab in patients with advanced solid malignancies.
Who can participate
Age range21 Years – 99 Years
SexALL
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Inclusion criteria
✓. Age ≥ 21
✓. Willing and able to provide written informed consent in accordance with local institutional guidelines.
✓. Dose Escalation Phase: Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry that is deemed unlikely to benefit from further standard therapy.
✓. Dose Expansion phase: Patients with previously treated, metastatic or advanced recurrence malignancy confirmed histologically or cytologically. Patients must have evidence of progressive disease on study entry that is deemed unlikely to benefit from further standard therapy.
✓. There is no upper limit on the number of prior treatments. Hormone ablation therapy is considered an anticancer regimen. Radiation and surgery are not considered anticancer regimens.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1.
✓. Adequate hepatic function within 14 days prior to C1D1:
✓. Total bilirubin \< 1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 × ULN), and
Exclusion criteria
✕. Subjects with vitiligo or alopecia
✕. Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
. Any chronic skin condition that does not require systemic therapy
✕. Subjects without active disease in the last 5 years may be included but only after consultation with the medical monitor
✕. Subjects with celiac disease controlled by diet alone
✕. For other autoimmune or inflammatory conditions not specifically mentioned - to discuss on case by case basis with investigator and medical monitor 15. BSA \<1.35 m2 (BSA calculated by Dubois or Mosteller methods)