Starting Immunotherapy and Chemo Tomorrow

Here it is--Keytruda plus Lenvima v. Carbo Taxol. I was very surprised to see Carbo Taxol (and any chemo) was excluded entirely for half the patients. This must be a brand new thing. https://www.clinicaltrials.gov/ct2/show/NCT03884101 The hypothesis is fascinating, last line especially: "It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS)."

To TeamT, absolutely. Thanks. I'm so sorry I was unclear. Please bear with me. Your study includes carbo taxol for both arms, which is as you note, standard, and considered ethical. I was just surprised to see this one trial at least that left out carbo/taxol/chemo for half the participants. I think the part about always offering carbo taxol/chemo for both arms and then adding immunotherapy for one half because of ethics was true until something like yesterday morning! They must be getting more confident about immunotherapy, which may help some on this board who are very against carbo taxol and other chemo, for various reasons. I am more neutral; I don't think carbo taxol works very well, but did it, because it's still recommended at this time. I will say others must think CT must not work that well if it's okay for this study to take it off the table. This landscape is changing so fast that it seems impossible to keep up. Enjoyed your posts very much; helping me learn and explore. I am looking for a study that will allow me as a carcinosarcoma/GCS Stage 1A with a low tumor mutation burden, no Lynch, MSS, and wild type P53. All of the studies I found so far are looking for recurrence OR Stages 3-4. Lots of exclusions--for example, the one comparing Keytruda and Lenvima alone to carbo taxol alone specifically excludes MMMT/GCS patients, a common thread that DR. Arend at ALA is trying to change. Yours allows carcinosarcoma patients (yay!) but I would have to be Stages 3-4 or recurrent or both, none of which I am. Because Stage 1As tend to recur for my cancer, I'm looking for therapies to prevent recurrence, something akin to taking tamoxifen or aromatase inhibitors as breast cancer survivors routinely do. Thank you so much.

You're amazing and you have already contributed so much to me. I'm tearing up. I wish you all the best and hope this trial knocks it out! What a club indeed...one where you become a member without even trying and meet some wonderful people...but the dues are really high. :-(

I was on Keytruda for 4 1/2 years until all my glands were toast in fact. I started as 3cII and had liver mets grow while on chemo. Surgery 2-15 and I am still here, but I now have type 1 diabetes, hypothyroidism, Cushing etc so don't think Keytruda is without side effects if you are on it long enough, but all good. I got it for free from Merck, no trial for me I was not interested in adding anything to Keytruda.