"Bradley Monk, MD, a professor on the Clinical Scholar Track at the University of Arizona College of Medicine, Phoenix and a gynecologic oncologist at Arizona Oncology (US Oncology Network), discusses the phase 1b/2 innovaTV 205 (ENGOT-cx8/GOG-3024; NCT03786081) trial in patients with recurrent or metastatic cervical cancer.
This study is looking at the combination of tisotumab vedotin plus bevacizumab (Avastin), pembrolizumab (Keytruda), or carboplatin (Paraplatin). Testing these combinations makes sense biologically and mechanistically, according to Monk. The patients on this trial, who progressed on their second-line of therapy or later, will be in 1 of the 3 dose-escalation arms. The investigators identified the appropriate doses of tisotumab plus each of the 3 other therapies.
Monk explains that in the same space where these agents are used in earlier lines of therapy, the investigators will see how they will affect patients by way of dose expansion. To find the recommended phase 2 dose, patients will receive therapy with 1 of the combinations every 3 weeks. Because the half-life is only 1.7 days, there will be a fourth arm in the phase 2 looking at weekly dosing.
There will be an interim analysis after 15 patients are enrolled in each arm. The primary end point is overall survival. Monk says the investigators are also interested in the adverse events associated with these combinations. One adverse event associated with tisotumab is epistaxis, an eye toxicity, which they have a mitigation strategy for of eye drops. Patients on this drug also can also experience fatigue and neuropathy.
This study is looking at the combination of tisotumab vedotin plus bevacizumab (Avastin), pembrolizumab (Keytruda), or carboplatin (Paraplatin). Testing these combinations makes sense biologically and mechanistically, according to Monk. The patients on this trial, who progressed on their second-line of therapy or later, will be in 1 of the 3 dose-escalation arms. The investigators identified the appropriate doses of tisotumab plus each of the 3 other therapies.
Monk explains that in the same space where these agents are used in earlier lines of therapy, the investigators will see how they will affect patients by way of dose expansion. To find the recommended phase 2 dose, patients will receive therapy with 1 of the combinations every 3 weeks. Because the half-life is only 1.7 days, there will be a fourth arm in the phase 2 looking at weekly dosing.
There will be an interim analysis after 15 patients are enrolled in each arm. The primary end point is overall survival. Monk says the investigators are also interested in the adverse events associated with these combinations. One adverse event associated with tisotumab is epistaxis, an eye toxicity, which they have a mitigation strategy for of eye drops. Patients on this drug also can also experience fatigue and neuropathy.
