Second Clinical Trial:

[missyrand]

After consulting with our oncologist in Virginia, our former trial study doc, NIH, and Georgetown University, my husband has decided to participate in another clinical trial at Georgetown.

This study has two arms, and he will be in the monotherapy only, Part 2 group, if accepted. This part of the study is investigating a drug identified as CMP-001and is delivered directly into a cutaneous (skin) visible tumor of at least .5 cm. The process is an injection once per week for 7 weeks, then every 3 weeks until there is either disease progression (bad) or the physician determines there has been enough progress in improvement (good). Scans to assist in objective response rate happen every 12 weeks (the usual CT, PeT, or MRI process involving camel spit barium). Premise is that the injected medication will produce an inflammatory response to jump start the immune system across the body so the melanoma will be recognized and destroyed. Right now, Wayne's immune system is not recognizing the cancer as "other" and so it is progressing in growth (again, bad).

Since this is a multi-center Stage 1B trial, it is also happening at other hospitals. Here is the full link from NIH clinical Trials if you are interested in learning more: clinicaltrials.gov/ct2/show...

Wayne has had a lot of nausea this past week and we think the culprit was an attempt to return to use of an anti-depressant (Lexapro) so he stopped it 3 days ago and is slowly improving. We met with a palliative care physician yesterday, and felt re-assurred that we are doing all we can and have good questions to ask ourselves, our care providers, and information to share with our family and support systems. I'm grateful to include this online community in my support system Thank you.

Next week is screening with study beginning week of Oct. 7.

Coping update: We are crying less, and sleeping better, watching Downton Abby and the new season of the Great British Baking Show to keep us away from stressful US politics, and our cat, Miss Scarlett, continues to provide comfort 24/7 to us both. Tonight we will go watch the Nats play the Indians with dear friends who provided me with weeks of housing when Wayne was in the TIL trial at VCU in May.

Peace,

Missy

[carlsbad317]

❤️ Prayers and love to you.

[doulagirl]

So glad you have a path that makes sense to you.

Will the drug be injected in more than one spot or do they expect the inflammatory /immune reaction with one spot injection only? I am interested and will look into this. Thank you for always providing us with such useful info.

Praying for you guys as always <3

[missyrand Ambassador in reply to doulagirl]

I think the injections will be repeated into the same tumor each time, but I’ll know more after the appointment Wednesday and will report back. Thanks for asking

Missy

[missyrand Ambassador in reply to doulagirl]

The drug is definitely injected into the same tumor each time and the study will use a location that had shown up in the recent weeks on his back. Premedication is a lot of IV Benedryl before surgical PA does the injection.

Yet another diagnostic CT scan needed because protocol requires one within 30 days before first injection, so more camel spit for Wayne.

Treatment days will be on Wednesday

Peace

Missy

[doulagirl in reply to missyrand]

Ok, thank you for the follow up. That makes a lot of sense ! I am so hoping and praying this works out for Wayne <3

[strawberryjam]

So happy you found a second clinical trial. I have heard that injections into tumors with meds that amp up the immune system can really work well. I am hoping that is exactly what happens for your husband. Wishing you all the best.

[MeAndMom]

Hi Missy, I just saw this update now after writing you earlier. It sounds similar in concept to the PV-10 combo trial (2B) my mother did (I believe they are using PV-10 for liver mets too). She had to quit but we saw interesting results on the injected tumors (the trial included multiple palpable tumors including ultrasound guided ones).

Also - is the Ipi/Nivo combo an option for those who have failed them individually (my mother failed adjuvant ipi and twice pembro)? I’ve read in the FB groups that people are doing this..

Best, Nadia

[missyrand Ambassador]

Nadia,

I'm not sure what the viability of combo Ipi/Nivo if previously not helpful. It may matter why the intervention was not helpful: was it due to side effects? If so, the combo has higher propensity for grade 3 side effects. It can also be not as helpful for different genetic tumor groups. I would ask your oncologist directly about applicability for your situation and why or why not this could be helpful. There is growing data on the combo of Ipi and Nivo for effectiveness. Like you, we are still learning though why a group of people are more likely to get results from the combo vs single agents, and why others don't respond well to either. I can't remember if your mom is Wild type like Wayne? Although we have a member of our support group who had very advanced (mets in brain, Lungs and liver) who was in the combo trials, had a single dose of the combo and experienced very serious reaction that landed him in hospital, then continued with Nivo only, but has been NED since. And he was in the shorter treatment arm (12 months instead of 24). He was just a great responder even as Wild type. To me, this is just a combination of science and luck because it isn't all figured out yet.

PV-10 is the Rose bengal injection, so the guided process into the liver is like the current trial with TVEC into the liver mets sponsored by Amgen (

antidote.me/match/study-pag... ). In the trial Wayne is in the injections are into cutaneous locations, so not as invasive. Our study doc has seen up to 20% effectiveness with patients like my husband who have had progressive melanoma even with several immunotherapies, so we will see how it goes.

Peace,

Missy

[MeAndMom]

What immunotherapy has Wayne done in the past? Good question to figure out the numbers and success of people doing the combo after failing one.

Yes PV-10 is Rose bengal and the numbers are interesting for those injected in liver and sub and cutaneous tumors, but I’m not sure how robust for systemic treatment. It might be worth looking into for Wayne.

(My mom is not Wild type)

[missyrand Ambassador]

My husband had 42 rounds of Keytruda, 3 rounds of Yervoy, TIL protocol with 5 out of 6 possible doses of Interlukin2 post transplant ad part of that clinical trial which also involved 2 chemo therapies before the transplant as part of the protocol.

Also, a single dose of Remicaid between Yervoy and TIL to address chronic GI symptoms. So he’s had a shit ton of immunotherapy

Missy