New Arizona Trial: Nivolumab (PD-1 Immunotherapy) + XELIRI/Irinotecan

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New Arizona Trial: Nivolumab (PD-1 Immunotherapy) + XELIRI/Irinotecan

Postby DK37 » Sat Apr 25, 2015 9:16 am

This new trial just opened up in Arizona. NCT02423954 ... show_rss=Y

It looks like there are two CRC arms to the trial: Irinotecan + Nivolumab (PD-1 Immunotherapy) vs. XELIRI + Nivolumab
All trial participants will receive Nivolumab.

Although Nivolumab unfortunately does not have monotherapy activity against most CRC (especially MSS CRC), there is a chance that combining it with chemo as dual therapy may benefit more patients. This strategy is complicated though since in addition to displaying antigens from dying cancer cells for the immune system to latch on to, cytotoxins can have a complicated mixture of pro-immune (make the tumor environment less immunosuppressed) and anti-immune (lower WBC counts) effects. This is truly a case that only a clinical trial can give a final answer. I could not find published animal mode data (maybe Grouseman or Maia can) - but it seems like they must have had some supportive preclinical data to get IRB support.

This trial may be interesting to discuss with your MD in particular for patients:
- Who live in/near Arizona and have trouble traveling further away for clinical trials making trial choices limited
- Patients interested in a "conservative" immunotherapy trial - since it is an add on trial to standard of care chemo rather than something exclusively novel.
In my experience, everyone is different where they are comfortable being on the risk spectrum, this trial is on the more conservative side compared to most immunotherapy trials.

Of note, usually once you do a PD-1 inhibitor trial - if needed, you are precluded from doing a different PD-1 trial in the future. Sometimes you are even precluded from additional non-PD-1 "checkpoint inhibitor" trials. Something to think about strategically since many different combinations are in progress/planned and it is unknown right now which combination will work best for CRC.

6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder:
2016 Colondar 2.0 Model
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Location: Southwest Michigan

Re: New Arizona Trial: Nivolumab (PD-1 Immunotherapy) + XELIRI/Irinotecan

Postby Ceebo » Sat Apr 25, 2015 9:39 am

Thanks for the great information! It's nice to know what's becoming available!!
DH 64 Stage 4 on 4/14 ; cecal tumor; 5+ nodes ; mets to liver; colon resection
9/14 - Liver surgery aborted; peri mets
10/14 CT mult.1-2 mm lung mets; FOLFIRI & Avastin
1/15 CT -liver & lung mets shrinking
3/15 PET - ? New met. site colon; CEA rising
7/15 Chemo has failed; looking for clinical trial
9/29/15 started TAS-102 trial
KRAS mutant; MSS

Posts: 37
Joined: Thu Sep 05, 2013 1:05 pm

Re: New Arizona Trial: Nivolumab (PD-1 Immunotherapy) + XELIRI/Irinotecan

Postby gator.girl » Sat Apr 25, 2015 9:39 pm

Thanks for posting DK!
Dx 8/13 @ 40
Stage IV - innumerable mets to liver
12 rounds of Folfox + Avastin
8 months on maintenance
11/14 Y90 to right side of liver
01/15 Gallbladder removal and colon resection
02/15 Mets to lungs
Now on Folfiri

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