A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms

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What is Nivolumab (Opdivo)

Nivolumab is a type of cancer treatment drug called an immunotherapy. It is a treatment for a number of different types of cancer. You might have it as part of a clinical trial for other types of cancer.

What is Temozolomide (Temodal)

Temozolomide is a type of chemotherapy.  It is well known in Neuroendocrine Cancer as the TEM in CAPTEM

Trial Summary

The purpose of the trial.  Treatment options are sometimes limited in patients with metastatic neuroendocrine neoplasms (NEN). The primary endpoint was response rate (using RECIST 1.1). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Immune profiling was performed by mass cytometry to evaluate the effect on peripheral blood immune cell subsets.

“In summary, the combination of temozolomide and nivolumab showed promising activity in NEN, especially in lung and pancreatic NEN. This study included patients with both NET and NEC and activity was seen across the spectrum of differentiation in NEN. 

This study has several limitations, including its single-arm, single-institution nature (see link  below Supplementary Table S5) with relatively short follow-up. The study population was also heterogeneous, and studies of patient subsets are limited because of small numbers. Biomarker studies were further limited by missing samples predominantly driven by lack of sample collection during the COVID-19 pandemic. The timing of immune analysis at day 15 may also be impacted by myelosuppression of temozolomide. Therefore, the immune exploratory analyses should be considered hypothesis generating. Given the single-arm combination nature of the trial, it is not possible to interpret the contribution of each drug to response or synergy of the combination therapy. Although the response rate observed in this study—especially in lung NEN—is higher than expected with either agent given alone, this combination warrants further study though to determine efficacy of temozolomide, nivolumab, or the combination.

In conclusion, combination nivolumab and temozolomide demonstrated promising efficacy in NENs, especially in patients with lung and pancreas NEN.”

(full study info referenced below)

Why is this trial important? 

Immunotherapy does not have a good track record so far, particularly in well differentiated NETs. This trial was interesting because of the wide collection of NET types and although the conclusion favoured Lung and Pancreatic NETs.

Well differentiated NETs comprised 71% of the trial population and there was a 50/50 split between Grade 1/2 and 3.

It’s disappointing that only Lung and Pancreas showed favourable responses but this adds to the fact that NENs are a heterogenous grouping of cancers. 

Read more here

1.  ClinicalTrials.gov Identifier NCT03728361: Click here
2.  Results summary. Cick here

What’s next?

It’s not clear, on paper the trial is no longer recruiting and the primary completion date has passed (31 Dec 2022).  The study completion date is currently recorded as December 31, 2023. 

Click to read more

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.  If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net

The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan. 



I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.  Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional as they are not members of the private group or followers of my sites in any official capacity.  Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.


Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product.  Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document  Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET

Thanks for reading.


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