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A Phase 1/2 Study of Durvalumab and IPH2201 in Adult Subjects with Select Advanced Solid Tumors (Sponsor Protocol Number: D419NC00001)
Protocol Number:
Phase I/II
Jarushka Naidoo
Johns Hopkins Kimmel Cancer Center in Baltimore
This research study is designed to see if the experimental combination treatment of Durvalumab (MEDI4736)and IPH2201, the study medications, are safe and tolerable in treating various solid tumor cancers.To determine the preliminary antitumor activity of Durvalumab in combination with IPH2201.To evaluate the effects of Durvalumab plus IPH2201 on the cells of the body and blood.
INCLUSION CRITERIA: -Subjects must have histologic documentation of advanced recurrent or metastatic cancer.-Subjects must have received and have progressed or are refractory to at least one line of standard systemic therapy in the recurrent/metastatic setting, with selected advanced solid tumors.-Subjects must have at least one lesion that is measurable by RECIST v1.1.EXCLUSION CRITERIA: -Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.-Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed.-Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of durvalumab and IPH2201.-Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable. Local treatment of isolated lesions for palliative intent is acceptable beyond the DLT-evaluation period with prior consultation and in agreement with the medical monitor.-Current or prior use of immunosuppressive medication within 14 days before the first dose.
The study consists of 2 parts: dose escalation and dose expansion. Subjects will receive durvalumab and IPH2201 via 2 separate IV infusions. Subjects will receive durvalumab and IPH2201 until unacceptable toxicity, documentation of confirmed progressive disease (PD), or documentation of subject withdrawal for another reason.
Last Update
12/12/2019 05:03 AM