New TIL trial NCT03412877 at NCI

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boswind
Posts: 74
Joined: Fri Apr 11, 2014 12:04 pm

New TIL trial NCT03412877 at NCI

Postby boswind » Mon Sep 02, 2019 3:10 pm

By visiting the website of Dr. Steven Roserberg’s lab of NCI today, I found he has another active TIL clinical trial that started last year in 2018 for solid tumors:
NCT03412877
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer

This trial is different from the one where Celine got successful treatment:
NCT01174121
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

The key sentence in NCT03412877’s description that I like very much is:
“Recent studies have shown that these TIL predominantly recognize unique mutated neoantigens expressed by the cancer not shared by other melanomas.”

Does anyone have experience with or have more info about this new TIL trial?
01.24.14 Male, DX @54 Rectosigmoid Cancer, MRI: T3N0M0
03.19.14 Completed 5-week Radia+Xeloda
05.07.14 Had surgery
02.25.15 CT showed stage 4 inoperable
03.15 - 08.15, folfox + Avastin
08.15 - 07.17, 5FU+leucovorin+Avastin
07.17 - 01.18, Folfuri + Avastin
02.18 - 03.19, Centuximab + Irinotecan
03.19 - 05.19, Keytruda
05.19 - 9.19, Folfox+Avastin
10.19 -01.20: Centuximab+Irinotecan
03.20 - 06.20: STIVARGA
07.20 - present: lonsurf+Avanstin
MSS, KRAS wt, BRAF wt
131 rounds of chemos received (as of 12.31.20)

NHMike
Posts: 2555
Joined: Fri Jul 21, 2017 3:43 am

Re: New TIL trial NCT03412877 at NCI

Postby NHMike » Mon Sep 02, 2019 5:35 pm

I had a look and didn't see that it's going after specific mutations. There are a lot of exclusions though.
6/17: ER rectal bleeding; Colonoscopy
7/17: 3B rectal. T3N1bM0. 5.2 4.5 4.3 cm. Lymphs: 6 x 4 mm, 8 x 6, 5 x 5
7/17-9/17: Xeloda radiation
7/5: CEA 2.7; 8/16: 1.9; 11/30: 0.6; 12/20 1.4; 1/10 1.8; 1/31 2.2; 2/28 2.6; 4/10 2.8; 5/1 2.8; 5/29 3.2; 7/13 4.5; 8/9 2.8, 2/12 1.2
MSS, KRAS G12D
10/17: 2.7 2.2 1.6 cm (-90%). Lymphs: 3 x 3 mm (-62.5%), 4 x 3 (-75%), 5 x 3 (-40%). 5.1 CM from AV
10/17: LAR, Temp Ileostomy, Path Complete Response
CapeOx (8) 12/17-6/18
7/18: Reversal, Port Removal
2/19: Clean CT

sdino
Posts: 85
Joined: Tue Mar 28, 2017 5:32 pm

Re: New TIL trial NCT03412877 at NCI

Postby sdino » Tue Sep 03, 2019 11:27 am

My Wife did the iTCR TIL trial NCT03412877 at NIH in late April 2019. She was the 5th person to undergo this treatment and the first person that had reactive neoantigens for TP53. However, it did not work. But since she has very highly reactive TILs.... Dr Rosenberg wants to do the Original TIL trial NCT01174121 on her in Sept. 2019. As far targeting mutations, they look for reactive neoantigens in the cells and use them. So it does not matter what type of mutations one has to get into this trial
Caregiver for Wife 54 yrs old
DX:11/16-CC sigmoid colon
Lung Mets: 25+ Bilateral ranging 4mm-5.0cm
MSS, KRAS-G12D; TP53
iTCR TIL Trial NCT03412877 4/19 to 7/19 Off trial, - Sept. 2019 TIL trial NCT01174121
CT Scans: 7/2020 lung met shrinkage 36%, 3 lung mets left, two Liver mets destroyed by TILs
Brain tumor removal 3/2020
CEA:16-11/16; 5 -9/18; 63 -8/19; 1 -1/20; 0.8-5/20

boswind
Posts: 74
Joined: Fri Apr 11, 2014 12:04 pm

Re: New TIL trial NCT03412877 at NCI

Postby boswind » Tue Sep 03, 2019 4:14 pm

Thanks. Wish your wife doing well in the TIL trial.

My KRAS-G12D is negative, but TP53 is positive. I have contacted NCI to start the screen process.
01.24.14 Male, DX @54 Rectosigmoid Cancer, MRI: T3N0M0
03.19.14 Completed 5-week Radia+Xeloda
05.07.14 Had surgery
02.25.15 CT showed stage 4 inoperable
03.15 - 08.15, folfox + Avastin
08.15 - 07.17, 5FU+leucovorin+Avastin
07.17 - 01.18, Folfuri + Avastin
02.18 - 03.19, Centuximab + Irinotecan
03.19 - 05.19, Keytruda
05.19 - 9.19, Folfox+Avastin
10.19 -01.20: Centuximab+Irinotecan
03.20 - 06.20: STIVARGA
07.20 - present: lonsurf+Avanstin
MSS, KRAS wt, BRAF wt
131 rounds of chemos received (as of 12.31.20)

Siti
Posts: 269
Joined: Thu Aug 01, 2019 10:58 am

Re: New TIL trial NCT03412877 at NCI

Postby Siti » Tue Sep 03, 2019 4:18 pm

Thanks for sharing. Really hope and pray that this would be successful for all of you and would open up new treatment options and better outcomes for everyone.
DH (54) DX on 5/7/19
Sigmoid|G3|LN:30/31|MSS|WT KRAS, NRAS, BRAF
7/19 PET distant LN para-aorta neck hip (0.5-1.5cm)
7/19 Lap resection
26/8 to 20/12/19 CAPEOX+Bev 7x
6/11/19 CT 3 cycle LN shrunk
1/20 Cap+Bev
4/20 TS-1+Bev due to bad HFS
NED 4 years
8/23 PET recurrence chest LN growing since Feb. CEA May(4.5>5.1>5.9)
9/23 Stopped Bev, CEA Sept(8.7) Radio 17x
11/23 PET 1+ supraclavicular LN, CEA (3.4>2.5)
12/23 Lymphadenectomy
1/24 Narrow margins, 1/5 +LN, 1.4cm +tissue, TMB (19)

Siti
Posts: 269
Joined: Thu Aug 01, 2019 10:58 am

Re: New TIL trial NCT03412877 at NCI

Postby Siti » Tue Sep 03, 2019 4:20 pm

Boswind — I see in your signature you’re MSS. Did keytruda work for you? From my understanding it’s only for MSI-H candidates.
DH (54) DX on 5/7/19
Sigmoid|G3|LN:30/31|MSS|WT KRAS, NRAS, BRAF
7/19 PET distant LN para-aorta neck hip (0.5-1.5cm)
7/19 Lap resection
26/8 to 20/12/19 CAPEOX+Bev 7x
6/11/19 CT 3 cycle LN shrunk
1/20 Cap+Bev
4/20 TS-1+Bev due to bad HFS
NED 4 years
8/23 PET recurrence chest LN growing since Feb. CEA May(4.5>5.1>5.9)
9/23 Stopped Bev, CEA Sept(8.7) Radio 17x
11/23 PET 1+ supraclavicular LN, CEA (3.4>2.5)
12/23 Lymphadenectomy
1/24 Narrow margins, 1/5 +LN, 1.4cm +tissue, TMB (19)

boswind
Posts: 74
Joined: Fri Apr 11, 2014 12:04 pm

Re: New TIL trial NCT03412877 at NCI

Postby boswind » Tue Sep 03, 2019 5:17 pm

I was the first MSS patient receiving Keytruda in the cancer center where I receive treatments. I pushed my oncologist a bit to receive the drug, because my TMB was 12, which is within top 3% of all MSS CRC patients. But the drug failed on me. Now the cancer center has raised the TMB threshold to 20 for a MSS patient to be eligible for the Keytruda treatment.
01.24.14 Male, DX @54 Rectosigmoid Cancer, MRI: T3N0M0
03.19.14 Completed 5-week Radia+Xeloda
05.07.14 Had surgery
02.25.15 CT showed stage 4 inoperable
03.15 - 08.15, folfox + Avastin
08.15 - 07.17, 5FU+leucovorin+Avastin
07.17 - 01.18, Folfuri + Avastin
02.18 - 03.19, Centuximab + Irinotecan
03.19 - 05.19, Keytruda
05.19 - 9.19, Folfox+Avastin
10.19 -01.20: Centuximab+Irinotecan
03.20 - 06.20: STIVARGA
07.20 - present: lonsurf+Avanstin
MSS, KRAS wt, BRAF wt
131 rounds of chemos received (as of 12.31.20)

Siti
Posts: 269
Joined: Thu Aug 01, 2019 10:58 am

Re: New TIL trial NCT03412877 at NCI

Postby Siti » Tue Sep 03, 2019 5:30 pm

Thanks Boswind. Do they take a new biopsy to measure the TMB? Is it done via blood test or sample of new tumour?
DH (54) DX on 5/7/19
Sigmoid|G3|LN:30/31|MSS|WT KRAS, NRAS, BRAF
7/19 PET distant LN para-aorta neck hip (0.5-1.5cm)
7/19 Lap resection
26/8 to 20/12/19 CAPEOX+Bev 7x
6/11/19 CT 3 cycle LN shrunk
1/20 Cap+Bev
4/20 TS-1+Bev due to bad HFS
NED 4 years
8/23 PET recurrence chest LN growing since Feb. CEA May(4.5>5.1>5.9)
9/23 Stopped Bev, CEA Sept(8.7) Radio 17x
11/23 PET 1+ supraclavicular LN, CEA (3.4>2.5)
12/23 Lymphadenectomy
1/24 Narrow margins, 1/5 +LN, 1.4cm +tissue, TMB (19)

boswind
Posts: 74
Joined: Fri Apr 11, 2014 12:04 pm

Re: New TIL trial NCT03412877 at NCI

Postby boswind » Tue Sep 03, 2019 6:25 pm

Most TMB tests are performed by Foundation One Medicine in Cambridge Mass. some hospitals like MSKCC have their own “TMB” type tests. If ordering a TMB test from Foundation One your oncologist needs to send a tumor sample to them.
01.24.14 Male, DX @54 Rectosigmoid Cancer, MRI: T3N0M0
03.19.14 Completed 5-week Radia+Xeloda
05.07.14 Had surgery
02.25.15 CT showed stage 4 inoperable
03.15 - 08.15, folfox + Avastin
08.15 - 07.17, 5FU+leucovorin+Avastin
07.17 - 01.18, Folfuri + Avastin
02.18 - 03.19, Centuximab + Irinotecan
03.19 - 05.19, Keytruda
05.19 - 9.19, Folfox+Avastin
10.19 -01.20: Centuximab+Irinotecan
03.20 - 06.20: STIVARGA
07.20 - present: lonsurf+Avanstin
MSS, KRAS wt, BRAF wt
131 rounds of chemos received (as of 12.31.20)

Siti
Posts: 269
Joined: Thu Aug 01, 2019 10:58 am

Re: New TIL trial NCT03412877 at NCI

Postby Siti » Wed Sep 04, 2019 4:12 am

Boswind — I am guessing it has to be a latest/new biopsy considering they need to find new TMB?

I was thinking of sending his surgery tumour slides/blocks to MSK to do a comprehensive MSK Impact analysis but I was also wondering if that’s useful as he’s already done a DNA test and we know he’s MSS and wild type tumour. Do you have any thoughts on that?

https://www.mskcc.org/blog/fda-authoriz ... ent-tumors
DH (54) DX on 5/7/19
Sigmoid|G3|LN:30/31|MSS|WT KRAS, NRAS, BRAF
7/19 PET distant LN para-aorta neck hip (0.5-1.5cm)
7/19 Lap resection
26/8 to 20/12/19 CAPEOX+Bev 7x
6/11/19 CT 3 cycle LN shrunk
1/20 Cap+Bev
4/20 TS-1+Bev due to bad HFS
NED 4 years
8/23 PET recurrence chest LN growing since Feb. CEA May(4.5>5.1>5.9)
9/23 Stopped Bev, CEA Sept(8.7) Radio 17x
11/23 PET 1+ supraclavicular LN, CEA (3.4>2.5)
12/23 Lymphadenectomy
1/24 Narrow margins, 1/5 +LN, 1.4cm +tissue, TMB (19)


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