Kidney Cancer Journal 121
xciting original research was reported at this year’s 17th
International Kidney Cancer Symposium (IKCS) in
Miami. With “Emerging Concepts and Therapeutic Trials
in Progress in RCC” as one of the themes for the sessions,
the Symposium provided a dynamic venue and a comprehensive
agenda for more than 300 attendees at this two-day
event, one of two international meetings each year sponsored
by the Kidney Cancer Association. From early phase clinical
trials of novel therapeutics to updates on pivotal, ongoing
studies, the IKCS offered a unique opportunity to gauge
progress on a broad spectrum of topics and envision how new
information could have translational importance. In this report,
we will cover a few select presentations of novel data
from therapeutic studies that have a potential for becoming
practice-changing once fully completed and reported.
Tailoring Therapy to Response: Addressing
Therapy Intensification & Discontinuation
by Dr Hans Hammers.
Dr Hammers described adaptive clinical trials in metastatic
RCC patients. BMS-669 is a phase 2 study comparing
first-line therapy using nivolumab with salvage nivolumab+
ipilimumab. Patients (120 ccRCC, 40 nccRCC) initially
receive nivolumab only. Patients with a partial
response (PR) or complete response (CR) continue
nivolumab alone for up to 84 weeks, or until progression
of disease (PD) or severe toxicity, while those with progressive
disease or stable disease (SD) get re-induced with
nivolumab, with the addition of ipilimumab for 4 doses
and then receive nivolumab alone until progression of
disease or severe toxicity or 48 weeks. Patients who
progress on the first arm can be potentially considered
for enrollment on the second arm.
TITAN is a phase 2 trial (200 ccRCC) where patients
received nivolumab induction, and may continue
nivolumab alone if they experience a PR or CR. Patients
who have SD or PD receive nivolumab+ipilimumab (2
doses), and can go back to nivolumab alone if they experience
CR or PR, or receive another 2 doses of
nivolumab+ipilimumab if they experience SD or PD.
These patients can go back to nivolumab alone if they
experience CR, PR, or SD. Similar to BMS-669, patients
who initially responded to nivolumab alone can later receive
nivolumab+ipilimumab if they experience PD.
OMNIVORE is a phase 2 trial (58 patients) where patients
receive nivolumab and are assessed at 8 weeks initially.
If patients experience PR or CR which is con-
firmed, nivolumab is discontinued, and restarted at progression.
At progression, ipilimumab is added to
nivolumab for 2 doses only. If SD, PR, or CR, nivolumab
is continued until progression. If PD after nivolumab+ipilimumab,
therapy is discontinued. Alternatively, if patients
experience SD or PD after induction with
nivolumab, then similar to the first arm, ipilimumab is
added to nivolumab for 2 doses only. If SD, PR, or CR,
nivolumab is continued until progression. If PD after
nivolumab+ipilimumab, therapy is discontinued.
Phase 1 trials are investigating cabozantinib+nivolumab+
ipilimumab, PEG-IL2 with nivolumab or nivolumab+
ipilimumab, hypofractionated radiation therapy
to any RCC site along with treatment with pembrolizumab
(RadVax), SBRT+nivolumab+ipilimumab, cabozantinib+
nivolumab with or without ipilimumab,
NKTR-214 (pegylated IL-2) + nivolumab with or without
ipilimumab.
Other combinations that are reading out from phase
3 trials include avelumab+axitinib (JAVELIN Renal 101),
pembrolizumab+axitinib (KEYNOTE-426). PDIGREE was
CONFERENCE HIGHLIGHTS
International Kidney Cancer Symposium
IKCS Recaps Impressive Progress in Ongoing Pivotal Trials
and Projects New Directions in Novel Therapeutics
Jose A. Karam, MD, FACS
Associate Professor, Departments of Urology
and Translational Molecular Pathology
The University of Texas MD Anderson
Cancer Center
Houston, Texas
E