The Land of Clinical Trials: Immunotherapies

This is the second background post to cover information on some of the treatment options available to me. The first post discussed the different types of treatments in general, and this one covers the choice between approved treatments versus clinical trials, and the specific choices I had between various treatments. Immunotherapy is the logical first step for my treatments, at least until I have a biopsy and get the results of genetic analysis. That’s true both inside and outside of clinical trials, so it will be the focus of the post.

clinicaltrial

I fall into a weird spot in the cancer treatment system: while I have lung cancer now, it’s not clear whether it was a metastasis of the head and neck cancer I had in 2012. It’s the same type of cancer (squamous cell carcinoma) and also very strongly positive for HPV (HP16). So my situation is different inside and outside the land of clinical trials.

Outside the land of clinical trials, I have two avenues available: drugs approved for head and neck squamous cell carcinoma (SCCHN) or drugs approved for non-small-cell lung cancer (NSCLC). Currently there are two main immunotherapy drugs approved for use with NSCLC: Opdivo and Keytruda.

keytrudaopdivo

There are no immunotherapy drugs approved for use with SCCHN, so the only way I would have insurance approval for these drugs outside of clinical trials is to have them prescribed to treat NSCLC.

Here’s a good quick view of how some immunotherapy drugs like Keytruda and Opdivo work. There are other approaches to immunotherapy that I’ll describe when I talk about my specific options in the next post.

immunotherapy

Inside the land of clinical trials, it’s unlikely I would be accepted into a trial that focuses just on NSCLC or where SCCHN isn’t included as a cancer covered by the trial, since this could be considered a metastasis of SCCHN and trial inclusion rules are very strict. So in this case I’m limited just to trials that specifically include SCCHN as one of the cancers covered. There are also more broad “solid tumor” trials that cover a variety of different cancer types, and I would qualify for those as well.

Clinical trials have phases that determine not only how many patients are involved, but what the goals are for the trial.

what-is-a-phase-i-clinical-trial-3-638Most of the trials available to me are phase 1 or phase 2 because the research into immunotherapy is so new, and because SCCHN is rare compared to other more common cancers like lung or breast.

There are two types of trials available to me: combination trials, and novel drug trials.

  • Combination trials include more than one drug. Generally one of the drugs has already been through trials that at least prove baseline effectiveness, or it’s already available on the market, while the second drug is more new or at least untested in combination with the first.
  • Novel drug trials feature an all-new drug. Sometimes you get into the trial for the second or third phase, where there is some sense of the treatment’s effectiveness, but it’s often at phase 1 where even the effective safe dosage is still being worked out.

Most trials have a specific list of inclusion and exclusion criteria that patients must meet in order to be included. These criteria include the type of cancer, your general health status, your current cancer stage and treatment options, and sometimes specifics about how/when you’ve been previously treated. Almost all the trials for novel drugs are restricted to patients in my situation: metastatic cancer that failed first-line treatments. These drugs aren’t even tested as potential first-line treatments for anything but Stage IV or metastatic patients until they’ve been proven in trials like the ones I’m considering.

That’s a quick look at the background behind some of the decisions I’m making about my treatments. Next post, I’ll discuss my actual choices and next steps.

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