Bradley Monk, MD

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.

<< View more resources and information in gynecologic cancer

Videos

Bradley Monk, MD, discusses the phase 1b/2 innovaTV 205 trial in patients with recurrent or metastatic cervical cancer.

Investigating Combinations in Recurrent or Metastatic Cervical Cancer

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses trabectedin as a potential agent to treat ovarian cancer.

Read about research into ovarian cancer > >

Articles

Trabectedin as a Treatment Option for Patients with Ovarian Cancer

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses the utility of bevacizumab for the treatment of cervical cancer.

Bevacizumab has been looked at in many solid tumors, including ovarian cancer.

Treatment options for patients with cervical cancer are limited.

Bevacizumab plus chemotherapy elicits a survival advantage in this population.

MORE: Bevacizumab Receives Priority Review for Advanced Cervical Cancer > >

Bevacizumab for Cervical Cancer

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses clinical trial endpoints and individualizing treatment in patients with ovarian cancer.

The last approved agent in advanced epithelial ovarian cancer was the carboplatin + gemcitabine doublet used in platinum-sensitive recurrence

This doublet was approved based on a PFS endpoint

Since then, it has been difficult to get ovarian cancer drugs approved based on a PFS endpoint

The challenge remains to see the value of PFS

Maintaining long term tumor control, though of value to the patient, may not be of value to regulators

Though certain agents may be equally efficacious, they may have different toxicity profiles

Ideally, clinicians need agents approved on a PFS endpoint in order to individualize treatments

Bradley Monk, MD | Authors

Articles

Investigating Combinations in Recurrent or Metastatic Cervical Cancer

Trabectedin as a Treatment Option for Patients with Ovarian Cancer

Bevacizumab for Cervical Cancer

Individualized Treatments and Clinical Trial Endpoints in Ovarian Cancer