Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 3

4441 - “A pilot study of tremelimumab (treme) with or without cryoablation (cryo) in patients (pts) in metastatic renal cell carcinoma (mRCC).”

Date

30 Sep 2019

Session

Poster Display session 3

Topics

Tumour Site

Renal Cell Cancer

Presenters

Matthew Campbell

Citation

Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249

Authors

M.T. Campbell1, S. Martin2, A.L. Tam3, R.A. Sheth3, S. Singh4, K. Ahrar3, B. Slack Tidwell5, P. Rao6, J.A. Karam7, C.G. Wood8, N.M. Tannir9, E. Jonasch10, J. Gao11, A.Y. Shah8, J.M. Blando4, F. Duan4, S. Basu4, J. Allison4, P. Sharma12, S. Singh4

Author affiliations

  • 1 Genitourinary Medical Oncology, The M. D. Anderson Cancer Center, 77030 - Houston/US
  • 2 Urology, The University of Texas MD Anderson Cancer Center, 77002 - Houston/US
  • 3 Interventional Radiology, MD Anderson Cancer Center, 77030 - Houston/US
  • 4 Immunology, MD Anderson Cancer Center, 77030 - Houston/US
  • 5 Biostatistics, MD Anderson Cancer Center, 77030 - Houston/US
  • 6 Pathology Admin, MD Anderson Cancer Center, 77030 - Houston/US
  • 7 Urology, MD Anderson Cancer Center, 77030 - HOUSTON/US
  • 8 Genitourinary Medical Oncology, MD Anderson Cancer Center, 77030 - Houston/US
  • 9 Department Of Genitourinary Medical Oncology, MD Anderson Cancer Center, 77030 - Houston/US
  • 10 Gu Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 11 Genitourinary Medical Oncology, The University of Texas M. D. Anderson Cancer Center, 77030-4095 - Houston/US
  • 12 Genitourinary Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 4441

Background

Cryo is an effective intervention for palliation and local control for small primary and metastatic tumours in mRCC. Pre-clinical murine tumour modeling found cryo recruits effector immune cells and synergizes with anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) to inhibit tumour rechallenge as compared to either therapy (tx) alone, leading to a prospective pilot study evaluating safety/tolerability.

Methods

NCT02626130 randomized pts to treme (CTLA-4) 10mg/kg every 4 weeks alone (arm A) or after cryo (arm B) for two doses followed by surgery (sx) or biopsy (bx) followed by maintenance treme. Best confirmed responses (ORR) were defined using RECIST v1.1, toxicity (tox) tabulated using CTCAE v4 with ≥ grade 3 adverse events (AE) possibly related reported, and time on study was defined as event free survival (EFS). Immune monitoring data (IMD): tissue based IHC, CyTOF, and RNA Nanostring.

Results

30 pts accrued, 29 pts received tx on study. More patients in Arm B had intermediate and poor risk disease as per IMDC criteria and had received >1 line of treatment as compared to Arm A leading to an imbalance between arms. Toxicity on study was similar between arms with six patients on each arm requiring treatment discontinuation due to AEs. IMD found clear cell histology (CC) had an inflamed tumor microenvironment (TME) with increased immune infiltration (IC) post treme in both arms compared to non-clear cell (NCC). CyTOF analysis identified an activated CD4+ T cell cluster expressing ICOS in the TME of CC pts compared to NCC.

Conclusions

Cryo+treme was tolerated similar to treme alone. IMD found a differential TME response to treme in CC vs NCC pts and in EFS >3 mo vs EFS <3 mo. Longer follow up is needed to determine impact of cryo in clinical efficacy endpoints.Table:

963P

Arm A n = 14Arm B n = 15
Histology Clear cell (CC) Non-clear cell (NCC) 9 5 9 6
IMDC Good (CC/NCC) Intermediate Poor 4 (4/0) 9 (5/4) 1 (0/1) 0 11 (6/5) 4 (3/1)
Prior nephrectomy7 (50%)5 (33%)
Prior treatment 0 1 >1 10 2 2 10 0 5
Tissue collected6 sx, 4 bx, 4 no tissue5 sx, 4 bx, 6 NT
ORR All (CC/NCC) PR SD PD Not measurable 0 9 (7/2) 3 (2/1) 2 (0/2) 1 (1/0) 4 (3/1) 5 (1/4) 5 (4/1)
EFS mo (Arm A v Arm B)4.9 vs 3.2 (HR 0.73, 95%CI 0.35-1.58)
EFS mo (CC v NCC)3.3 vs 2.9 (HR 1.16, HR 95%CI 0.54-2.51)
EFS > 6 mo, #pts, (range)Arm A: 4 (7.6-29.9), Arm B: 3 (6.3-30.3)
EFS> 6 mo (range) CC v NCCCC: 4 (11.7-30.3), NCC 3 (6.3-7.8)

Clinical trial identification

NCT02626130.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

AztraZeneca.

Disclosure

M.T. Campbell: Honoraria (self): Pfizer; Honoraria (self): Genentech; Honoraria (self): Apricity Health LLC; Advisory / Consultancy: EMD Serono, Inc; Advisory / Consultancy: Genentech, Inc. E. Jonasch: Research grant / Funding (self), Research grant / Funding (institution): Exelixis; Research grant / Funding (self), Research grant / Funding (institution): Novartis; Research grant / Funding (self), Research grant / Funding (institution): Peloton; Research grant / Funding (self), Research grant / Funding (institution): Pfizer; Honoraria (self): Eisai; Honoraria (self): Exelixis; Honoraria (self): Genentech; Honoraria (self): Ipsen; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Roche. A.Y. Shah: Honoraria (self): Eisai; Honoraria (self): Oncology Information Group; Honoraria (self): Roche Pharmaceuticals; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): BMS; Research grant / Funding (institution): EMD Serono. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.