A Phase 1 Study to Evaluate the Safety and Tolerability of Anti-PD-L1, MEDI4736, in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Trial ID # NCT01975831
Phase I
Drug Class Immunotherapy: Checkpoint Inhibitors/CTLA-4
Drug Name Tremelimumab
Alternate Drug Names Ticilimumab, CP-675206, CP-675,206, CP-675, anti-CTLA4 human monoclonal antibody CP-675,206
Drugs in Trial Durvalumab, Tremelimumab
Eligible Participant

Advanced solid tumors

Patients Enrolled

104 (30 ovarian)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, evaluated per irRECIST

Efficacy

ORR: 7.4% (2PR, n=27)
DCR: 44.4% (2PR, 10SD, n=27)
DoR: 10.8 months (5.6-15.9 months)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: any (14.4%)

Conclusion

Tremelimumab+durvalumab has a manageable safety profile with preliminary evidence of clinical activity

Reference

Callahan MK et al. Phase 1 study to evaluate the safety and tolerability of MEDI4736 (durvalumab, DUR) + tremelimumab (TRE) in patients with advanced solid tumors. J Clin Oncol (2017) 35 (suppl; abstr 3069)
https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.3069

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