Abstract 3560
Background
Brain metastases are a known complication of metastatic melanoma and often result in debilitating neurological conditions or death. Pts with MBM are typically excluded from trials, however, MBM-specific trials have been designed to assess the impact of systemic therapy in this challenging population. Combination immunotherapy has demonstrated a high rate of intracranial activity in pts with asymptomatic MBMs. However, many do not quallify during the screening period and never initiate protocol. We sought to determine the treatment patterns and therapeutic outcomes in pts considered for MBM-specific trials but screen failed before initiating treatment.
Methods
We reviewed the outcomes of pts considered for 2 MBM-specific trials that enrolled pts with untreated MBM at MD Anderson Cancer Center, CheckMate 204 (NCT03175432) and BEAT-MBM (NCT02320058). Both studies had cohorts that allowed symptomatic pts or pts requiring steroids. We performed a retrospective medical record review of pts who failed screening to CM204 and BEAT-MBM.
Results
We initially screened 65 pts and 38 screen-failed: 17 pts (50%) for BEAT-MBM and 21 pts (68%) for CM204. Of these, 15 received Ipi, Nivo, or combination off study. 5 (33%) responded to treatment and have maintained response. 10 pts received Ipi + Nivo and 3 (30%) of these maintained durable responses. 2 received Ipi alone (13%) and 3 received Nivo alone (20%). All pts received systemic therapy before radiation. Of the 5 responders, 2 received WBXRT after Ipi + Nivo. The remaining 23 pts received either targeted therapy (6), radiation alone (2), other immunotherapy +/- radiation (3), or no treatment (12).
Conclusions
Given the limited number of trials available to pts with MBM and high rate of screen failure (over 50% in our population), there is an unmet need that needs to be addressed. Of those patients that fail screening, many are eligible for systemic therapy off protocol. Pts with MBM treated with Ipi + Nivo off study still experienced therapeutic benefit. Given the high rate of screen failure in pts with MBM, there is a need for modification for eligibility criteria and the screening process to expedite on-protocol therapy in this vulnerable population.
Clinical trial identification
CheckMate 204 (NCT03175432) and BEAT-MBM (NCT02320058).
Editorial acknowledgement
Legal entity responsible for the study
The University of Texas M.D. Anderson Cancer Center.
Funding
The University of Texas MD Anderson Cancer Center, Bristol-Myers Squibb, Genentech.
Disclosure
I. Glitza Oliva: Advisory / Consultancy, Speaker Bureau / Expert testimony: Array; Advisory / Consultancy, Research grant / Funding (self): BMS; Research grant / Funding (self): Merck. R.N. Amaria: Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Iovance; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Array. S. Patel: Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy: Cardinal Health; Advisory / Consultancy: Castle Biosciences; Research grant / Funding (institution): Deciphera; Advisory / Consultancy: Immunocore; Advisory / Consultancy: Incyte; Speaker Bureau / Expert testimony: Merck; Research grant / Funding (institution): Provectus; Advisory / Consultancy, Research grant / Funding (institution): Reata; Research grant / Funding (institution): Novartis. P. Hwu: Advisory / Consultancy, Shareholder / Stockholder / Stock options: Iovance Biotherapeutics; Shareholder / Stockholder / Stock options: Immatics; Research grant / Funding (institution): Genentech; Advisory / Consultancy: Dragonfly Therapeutics; Advisory / Consultancy: Glaxosmithkline; Advisory / Consultancy: Sanofi. M.A. Davies: Advisory / Consultancy: Glaxosmithkline; Advisory / Consultancy: Genentech/Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Vaccinex; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Syndax; Advisory / Consultancy: Nanostring Technologies; Advisory / Consultancy: Array Biopharma; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Merck; Research grant / Funding (self): Oncothyreon; Research grant / Funding (self): Myriad Genetics; Research grant / Funding (self): Sanofi. H.A. Tawbi: Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Genentech/Roche; Advisory / Consultancy, Research grant / Funding (institution): Merck; Research grant / Funding (institution): Glaxosmithkline. All other authors have declared no conflicts of interest.
Resources from the same session
6008 - Quality of life in previously untreated patients with advanced renal cell carcinoma (aRCC) in CheckMate 214: updated results
Presenter: David Cella
Session: Poster Display session 3
Resources:
Abstract
3630 - Results of phase 1 clinical trial of high doses of Seleno-L-methionine (SLM) in sequential combination with Axitinib in previously treated and relapsed clear cell renal carcinoma (ccRCC) patients
Presenter: Yousef Zakharia
Session: Poster Display session 3
Resources:
Abstract
2356 - Safety and Efficacy of CDX-014 , an Antibody-Drug Conjugate against T Cell immunoglobulin mucin-1 (TIM-1), in advanced Renal Cell Carcinoma
Presenter: Bradley McGregor
Session: Poster Display session 3
Resources:
Abstract
1028 - SPAZO2 (SOGUG): Outcomes and prognostic significance of IMDC intermediate prognosis subclassification in metastatic renal cell carcinoma (mRCC) in patients treated with 1st-line pazopanib (1stPz).
Presenter: Begona P. Valderrama
Session: Poster Display session 3
Resources:
Abstract
2293 - Effect of Antacid Intake on the Therapeutic Efficacy of Sunitinib (SUN) in Metastatic Renal Cell Carcinoma (mRCC) Patients (pts): a Sub-Analysis of the STAR-TOR Registry
Presenter: Katrin Schlack
Session: Poster Display session 3
Resources:
Abstract
1451 - Randomized phase 3 trial of avelumab + axitinib vs sunitinib as first-line treatment for advanced renal cell carcinoma: JAVELIN Renal 101 Japanese subgroup analysis
Presenter: Motohide Uemura
Session: Poster Display session 3
Resources:
Abstract
4399 - Overall and progression-free survival according to MSKCC scores in 1st line sunitinib treatment of metastatic renal cell carcinoma (mRCC)
Presenter: Jindrich Finek
Session: Poster Display session 3
Resources:
Abstract
1344 - Combination therapy with checkpoint inhibitors for first-line treatment of advanced renal cell carcinoma: A systematic review and meta-analysis of randomized controlled trials
Presenter: Kyaw Thein
Session: Poster Display session 3
Resources:
Abstract
3462 - A phase II trial of TKI induction followed by a randomized comparison between nivolumab or TKI continuation in renal cell carcinoma (NIVOSWITCH)
Presenter: Viktor Grünwald
Session: Poster Display session 3
Resources:
Abstract
5268 - Nivolumab (N) treatment beyond progression in a real-world cohort of patients (pts) with metastatic renal cell carcinoma (mRCC)
Presenter: Sophie Hans
Session: Poster Display session 3
Resources:
Abstract