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Intratumoral BO-112 trial with pembrolizumab in patients with refractory unresectable stage III-IV melanoma who have progressed to anti-PD-1 based therapy.
THE PURPOSE OF THIS STUDY IS TO FIND OUT WHETHER BO-112, ADMINISTERED AS AN INJECTION IN MELANOMA METASTASES (WHEN THE TUMOR HAS SPREAD FROM THE ORIGINAL CANCER SITE TO ANY OTHER LOCATION), TOGETHER WITH INTRAVENOUS ADMINISTRATION (DIRECTLY INTO THE BLOOD VEINS) OF PEMBROLIZUMAB IS SAFE, WELL TOLERATED AND EFFECTIVE IN TERMS OF RESPONSES (DECREASE IN TUMOR SIZE OR NUMBER OF TUMORS).
- SINGLE-ARM PHASE II CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF INTRATUMORAL BO-112 WITH PEMBROLIZUMAB IN PATIENTS WITH REFRACTORY UNRESECTABLE STAGE III-IV MELANOMA WHO HAVE PROGRESSED TO ANTI-PD-1 BASED THERAPY
- Code EudraCT: 2020-003921-51
- Protocol number: BOT112-03
- Promoter: HIGHLIGHT THERAPEUTICS, S.L.
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