NCORP November 2015 Update

NCORP November 2015 Update

Michael A. Thompson, MD, PhD

@mtmdphd
Nov 23, 2015

A few brief updates from the November meetings of the Alliance for Clinical Trials in Oncology (Alliance) and ECOG-ACRIN Cancer Research Group, as well as upcoming meetings. Both recent meetings conducted individual tumor-specific discussions that I either couldn’t attend simultaneously or are outside the realm of a simple overview.

Alliance

I attended my first Alliance research base meeting this November in Rosemont, IL. This is a convenient location for many across the country with its proximity to O’Hare Airport. The meeting was well run and attended by some familiar, to me at least, and not-as-familiar National Clinical Trials Network (NCTN) faces. Many of the items from the NCI site NCORP meeting were reiterated and updated including clinical trial accrual metrics. The Alliance seems to be doing well in terms of accrual and new concepts in the pipeline. As a result of the Alliance merger, there has been a changeover in staff and integration. Of interest to NCORP sites, Cancer Care Delivery Research (CCDR) studies are in the pipeline, as well as cancer control, prevention, and therapeutic studies. It was noted that Alliance benefits from NCI as well as pharmaceutical sponsor support for continued trial expansion.

I and others have noted in the past in this tweet:

  • #Crowdsourcing #Cancer Clinical Trial Concepts from the General Public – @ALLIANCE_org http://ow.ly/oam2Y HT @FischMD @SWOG 

…that the Alliance encourages and facilitates: “HOW TO SUBMIT A CONCEPT (FOR THE GENERAL PUBLIC)”. While this may not be as advanced as some crowdsourcing or crowdfunding efforts, it is a start.

The NCI Molecular Analysis for Therapy CHoice (MATCH) EAY131 study has met the preplanned interim stopping (“pause”) threshold of 500 patients and is on hold for additional arms to be added and additional sample preparation infrastructure and standard operating procedures (SOPs). More information on this trial is presented later in this post. The Alliance meeting will be held twice yearly (not once yearly as was once anticipated) and the next meeting is May 12-14, 2016, at Loews Chicago O’Hare Hotel.

ECOG-ACRIN

The ECOG-ACRIN meeting was held November 12-14 in Orlando, FL. I discussed social media with groups of radiologists (#oncorad) and nurses (#OncRN), including the use of the Cancer Tag Ontology for sharing information using hashtags for oncology. This information was presented at the 2015 ASCO Annual Meeting and is now published in JAMA Oncology as “Disease-Specific Hashtags for Online Communication About Cancer Care.” We also reviewed use of the @EAOnc handle and #EAOnc hashtag to inform followers about ECOG-ACRIN clinical trials. A series of tweets included:

  • ECOG-ACRIN Active Clinical Trials http://ow.ly/snFqf #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Brain Cancer - #btsm http://ow.ly/snFUX #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Breast Cancer - #bcsm http://ow.ly/snG6o #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Early Detection, Diagnosis, and Prevention Active Trials http://ow.ly/snGkj #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Gastrointestinal (GI) http://ow.ly/Akw56 #EAOnc #ancsm #crcsm #hpbcsm #pancsm #stcsm
  • ECOG-ACRIN Active Clinical Trials - Genitourinary (GU) Cancer - #blcsm #kcsm #tscsm http://ow.ly/snPbQ #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Gynecological Cancer - #gyncsm http://ow.ly/snQ2l #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Head and Neck Cancer - #hncsm http://ow.ly/snQer #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Leukemia - #leusm http://ow.ly/snTwS #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Lymphoma - #lymsm http://ow.ly/snTGD #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Melanoma - #melsm http://ow.ly/snTYL #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Myeloma - #mmsm http://ow.ly/oUgfe #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Patient-centered Outcomes and Survivorship http://ow.ly/snUqi #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Thoracic Cancer - #lcsm http://ow.ly/snULK #EAOnc

NCI MATCH

As of the November 7, 2015, 720 patients were molecularly screened for the NCI MATCH study out of a planned 3,000. A few hundred had potential molecular matches based on current or future planned arms of MATCH with actionable targets. One patient (others are pending assessment) is on study drug out of a planned 1,000. It was noted that the response to molecular testing has been far more brisk and enthusiastic than anticipated. The MD Anderson Cancer Center (MDACC) was processing tumor tissue at approximately 20 per day instead of the planned 20 per week. Samples submitted were 85% adequate for tissue amount and quality. Overall, this resulted in more patients screened in the first wave of opened subprotocol studies. It is expected that subsequent waves of subprotocols will have more common actionable mutations as shown in the table.

Table. Subprotocol details of NCI MATCH clinical trial

Wave

Date active / planned

Subprotocol arms

Comments

1

8/12/15

10

ALK, ROS1, EGFR, BRAF, HER2, NF2, cKIT

2

1/2016

17

More common frequency mutations (RAS, PIK3CA, etc.)

3

4/2016

22

MET, mTOR, TSC1/2, FGFR, AKT

4

TBA

pending

 

It also was noted that multiple, sequential drugs in the same category may be used to enroll as a certain target/drug arm completes accrual. The NCI MATCH leadership is working to increase throughput at the tissue processing sites (MDACC) and the molecular laboratories (MDACC, Massachusetts General, NCI, Yale). There are 150+ NCI and NCTN members involved in the 10 subcommittees as well as patient advocates involved in trial design. So far MATCH has included only single agents; however, combinations are possible in the future for drugs with known recommended phase II doses. RNA and immunohistochemistry are being analyzed for research purposes. The proposed EAQ152 COMET: COMmunication & Education in Tumor Profiling protocol will be an ancillary to NCI MATCH. The PI for COMET is Dr. Bradbury. NCI has an updated MATCH website.

CCDR

Although there are no active ECOG-ACRIN CCDR studies, there are multiple concepts in the pipeline evaluating systems-based practice and heterogeneity of care in screening episodes, survivorship care planning, biomarker testing, and high-risk screening in the primary care setting. A second area of active concept development is financial health and toxicity in cancer care. These are in a variety of phases of maturation from completion of preliminary or preparatory research data phase to steering committee resubmission. The ECOG-ACRIN CCDR Chair is Ruth Carlos, MD.

Links and Hashtags for NCORP/NCTN Research Bases

NCORP Resources

Upcoming NCORP Research Base Meetings

2016

  • Jan 21-24 – NRG - Atlanta, GA
  • May 12-15 – ECOG-ACRIN - Boston, MA
  • May 12-14 – Alliance - Chicago, IL
  • Jul 14-17 – NRG - Dallas, TX
  • Nov 3-5 – Alliance - Chicago, IL

2017

  • Feb 9-12 – NRG - Location TBD
  • May 11-13 – Alliance - Chicago, IL
  • July 13-16 – NRG - Philadelphia, PA
  • Nov 2-4 – Alliance - Chicago, IL

Acknowledgements

I appreciate Ruth Carlos, MD, for editing the ECOG-ACRIN CCDR section and Joe Grundle from Aurora Research Institute for reviewing this blog post.

Note: This post was cross-published on Oncology Times.

Disclaimer: 

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Comments

Michael A. Thompson, MD, PhD

Feb, 10 2016 2:32 PM

NCI update:

NCI MATCH: A Status Report & Future Directions [2/1/16] - by Barbara Conley, MD

http://ow.ly/XROdG  


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