Serzan is a medical oncologist in the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, as well as an instructor of medicine at Harvard Medical School, located in Boston.

Dr. Michael Serzan 

Dr. Michael Serzan emphasizes the importance of clinical trial participation for patients with kidney cancer.

Breaking Down Clinical Trial Participation in Kidney Cancer: Is it Right for You?

The phase 1b STELLAR-002 study evaluated treatment with a new therapeutic called, zanzalintinib (XL092), which was evaluated in combination with Opdivo (nivolumab) and Opdualag (relatlimab-rmbw) in patients with clear cell renal cell carcinoma, according to Dr. Michael Serzan.

Serzan went on to emphasize that the combination therapy continues to be evaluated by investigators, though it remains a challenge to unseat or outperform the current standards of care for this patient population. However, performing these clinical trials remains of utmost importance so that physicians can continue to improve therapeutics and outcomes for patients.

In an interview with CURE, Serzan, a medical oncologist at the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and an instructor of medicine at Harvard Medical School, located in Boston, emphasized the importance of clinical trial participation for patients with kidney cancer, highlighting the need to also remain educated and informed on the topic.

What should patients ask their care teams if they’re interested in participating in a clinical trial like STELLAR-002 or accessing similar therapies in the future?

That's a great question. I always tell patients, whenever they receive a new cancer diagnosis, to ask their care team — whether it's their oncologist, urologist, or radiation oncologist — "Do you think I'd be eligible for a clinical trial?" If they are, then they should understand what that clinical trial entails.

I want to address a common myth that many patients believe: that clinical trials are only for those who have exhausted all other treatment options. That couldn't be farther from the truth. As we saw in the STELLAR-002 study, this is a brand-new combination with biological rationale that we hope will improve the standard of care. All drugs ever approved for cancer patients have gone through this type of study. So, I want to dispel the notion that clinical trials are only for patients who have exhausted all lines of therapy. I firmly believe they play a crucial role for patients across the entire disease spectrum.

If you are eligible for a clinical trial, it's important to discuss the potential benefits of enrolling, the potential risks or downsides, and some of the logistics involved. If your institution doesn't offer a clinical trial, I think it's very important to ask for a second opinion at an institution that does, because we are firm believers that it's the only way we advance the science of the field. Many times, patients receive even better care while on clinical trials because we are actively trying to move the field forward and using tomorrow's treatments today.

Transcript has been edited for clarity and conciseness.

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Treatment with zanzalintinib plus Opdivo and Opdualag is an option worth exploring in patients with previously untreated clear cell renal cell carcinoma 

Zanzalintinib Triplet Combo Under Investigation in Kidney Cancer Subgroups

Treatment with the triplet regimen of zanzalintinib (XL092) plus Opdivo (nivolumab) and Opdualag (relatlimab-rmbw) is a treatment option worth exploring in patients with previously untreated clear cell renal cell carcinoma, a type of kidney cancer, explained Dr. Michael Serzan 

The phase 1b study shared data from the dose-expansion cohort of the trial at the 

, which reported that when comparing the triplet combination with a doublet of just zanzalintinib and Opdivo, the triplet actually had a lower overall response rate (63% versus 40%). Despite this, Serzan says that the combination is still worth exploring.

It is also important to note that while the median follow-up for the doublet arm was 20.1 months, the median follow up for the triplet arm was just 15.9 months, meaning there is still a ways to go with exploring this treatment combination.

For patients who are newly diagnosed with clear cell renal cell carcinoma, how does this combination therapy of zanzalintinib and Opdivo with or without Opdualag 

compare to existing frontline treatment options

This was a relatively small study — a phase 1 trial with only 80 patients, 40 in each arm — designed primarily to see how well this combination was tolerated. When we try to compare it with currently available options, it’s important to remember those are different studies with different patient populations and medications, so it’s not a perfect comparison. However, we tend to make those comparisons anyway.

What I would say about the results from STELLAR-002 is that the side effects in the doublet — zanzalintinib plus Opdivo — versus the triplet — zanzalintinib plus Opdivo and Opdualag — were fairly similar. About a third of patients experienced side effects, which were [consistent] with what we typically see with these types of treatments. The most common ones were hypertension, diarrhea, liver and thyroid abnormalities, and skin rash. If patients experienced these side effects, we managed them by reducing doses or temporarily holding the medications.

One notable part of the presentation was that very few patients in either arm ended up stopping treatment altogether. Investigators seemed able to identify what was causing the side effects, hold the medication, and then resume treatment.

As for tumor responses: in the doublet arm, we saw a response rate of just over 60% and a disease control rate of about 90%. That means about 60% of patients had their tumors shrink, and about 90% had their tumors shrink or stay stable.

When we look at the triplet arm, we saw somewhat lower rates — a response rate around 40%, though the disease control rate was still about 90%. Again, small numbers here with 40 patients in each arm, but it’s intriguing; you’d think that the triplet would show a higher response rate versus the doublet, but we did not see that yet in this study.

We also looked at progression-free survival, which was actually a bit longer in the doublet arm at about 18 months versus about 13 months for the triplet. It is intriguing to see.

The primary end point was safety and tolerability, and these combinations seemed fairly similar in that regard. That said, it was a little [disappointing] that the triplet didn’t seem to produce better or longer responses. Still, this is a combination worth exploring, especially as we continue searching for new drugs and regimens for patients with kidney cancer.

Dr. Michael Serzan provides expert takeaways on treatment updates for patients with early-stage kidney cancer following the 2025 ASCO Meeting.

A New Therapeutic Approach May Make Waves in Kidney Cancer Treatment 

, key updates in the treatment of various cancers were shared with physicians and patients, including the treatment of newly diagnosed clear cell renal cell carcinoma, a type of kidney cancer. One such update for this patient population was from the phase 1b STELLAR-002 trial, according to Dr. Michael Serzan.

In an interview with CURE, Serzan walked through the key takeaways from the trial, what these outcomes mean for patients, and what next steps are for this combination, given these are still early days for the study.

To kick things off, what updates were shared at the 2025 ASCO Annual Meeting from the phase 1b STELLAR-002 study for patients who are newly diagnosed with clear cell renal cell carcinoma?

First, thank you so much for having me and for hosting this very important session to better inform patients and their caregivers about updates from ASCO 2025. My name is Dr. Michael Serzan, and I am a medical oncologist at the Dana-Farber Cancer Institute. I'm happy to walk through 

For some context, this study was conducted for patients with metastatic kidney cancer, meaning cancer that had spread to distant parts of the body. We are very fortunate to have many treatment options that have not only helped patients live better, but also live longer. This particular study aimed to investigate a new combination of therapies designed not only to shrink cancer, but hopefully to achieve long-term control. It looked at the safety, tolerability, effectiveness of the drugs, and how long patients remained on the study.

The STELLAR-002 study was a phase 1 trial that utilized the new VEGF TKI (Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor), zanzalintinib (XL092). This medication primarily targets the blood supply of clear cell kidney cancer and is very similar to a drug called Cabometyx (cabozantinib), which is one of our foundational treatments for kidney cancer patients. The key difference is that zanzalintinib has a much shorter half-life. This means if patients experience side effects and need to discontinue therapy, we can stop the drug, and those side effects may resolve more quickly.

The STELLAR program combined zanzalintinib with Opdivo (nivolumab), which is one of our standard immunotherapies. The second arm of the study looked at zanzalintinib plus Opdivo and Opdualag (relatlimab-rmbw), a new immunotherapy drug that targets the LAG-3 receptor on the surface of immune cells. The study was truly trying to determine if there were differences in how well the drugs were tolerated and how effective they were at treating the cancer when comparing the zanzalintinib/Opdivo arm versus the zanzalintinib/Opdivo/Opdualag arm.

Dr. Michael Serzan

Breaking Down Clinical Trial Participation in Kidney Cancer: Is it Right for You?

Zanzalintinib Triplet Combo Under Investigation in Kidney Cancer Subgroups

A New Therapeutic Approach May Make Waves in Kidney Cancer Treatment

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