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Tumor

Melanoma care varies by stage, with early cases being treated with surgery, whereas advanced disease often requires immunotherapy or targeted therapy.

What Patients Should Know About a Melanoma Diagnosis

The first patient has received CX-801 plus Keytruda in a phase 1 trial for metastatic melanoma, aiming to assess safety and early antitumor activity.

First Patient Dosed With CX-801 Plus Keytruda in Metastatic Melanoma

I would like to nominate Ashley Tullio, RN, for the Extraordinary Healer Award for Oncology Nursing. 

Fighting for Patients, Processes and Education 

AU-007, combined with Opdivo and low-dose aldesleukin, has entered a phase 2 melanoma trial, with early data showing activity and manageable safety.

AU-007 Combo Dosing Begins in Melanoma Phase 2 Trial With Opdivo

KSQ-004EX is being evaluated in solid tumors including melanoma, non-small cell lung, head and neck, colorectal, pancreatic and cervical cancer.

First Patient Dosed With KSQ-004EX In Solid Tumor Clinical Trial

For Melanoma Awareness Month, Dr. Douglas Johnson explains how stage and features of the disease can guide treatment decisions after diagnosis.

Expert Shares Key Insights During Melanoma Awareness Month

In recognition of Melanoma Awareness Month, CURE spoke with Dr. Douglas Johnson about what people need to know after a melanoma diagnosis, including how the disease is staged and treated. Understanding the depth and features of the melanoma — such as whether it’s ulcerated — is key to determining whether surgery alone is enough or if additional treatment is needed.

Johnson is a physician-scientist and professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee, where he leads the melanoma clinical research program. He explained that for patients with very early-stage melanoma — often defined as tumors less than 0.75 or 1 millimeter deep — treatment may involve only a wide local excision, typically performed by a surgeon or dermatologist.

If the melanoma is deeper or presents with more concerning features, patients may require further evaluation to assess lymph node involvement. This could lead to additional surgery, and in some cases, further therapy based on the surgical findings.

CURE: For patients newly diagnosed with melanoma, what are the most important things to know about the disease and its treatment options today?

: It certainly depends on a number of factors, and certainly the staging of the melanoma is important to think about. [This is] because it affects where patients need to go, as far as their next step. Usually a biopsy is done, and that's how a patient would know that they might have melanoma. It really depends how deep them the melanoma is. That's probably the first consideration that we think about when figuring out what the next steps are and whether the melanoma has what's called an ulceration on the top of it, and those factors would potentially determine what the next steps are.

If a patient has a very early-stage melanoma — defined as is less than 0.75 or less than one millimeter — then they would just have surgery alone. Usually something like a wide local excision and then that would be it. Patients may have that with surgery [and have checks with their dermatologist].

If [the cancer is] a little bit deeper than they would need to see a surgeon and then understand whether they have any lymph node involvement as well and have a bit bigger of an operation. Depending on what's found at those operations, then we need to think about any sort of additional treatment after that.

Transcript has been edited for clarity and conciseness.

For more news on cancer updates, research and education, don’t forget to 

Immune Therapy Expands Melanoma Treatment to More Patients 

Immune therapy is generally better tolerated than chemotherapy in treating melanoma, allowing more patients to receive treatment, including those with heart, lung or kidney conditions, according to Dr. Douglas Johnson.

Johnson is a physician-scientist and professor of medicine in the Division of Hematology/Oncology at Vanderbilt University Medical Center, where he leads the melanoma clinical research program, located in Nashville, Tennessee.

While people with severely limited physical function or serious autoimmune diseases may face challenges, many can still be treated with care from a specialist. Organ transplant recipients are a unique group at risk of rejection, but research is exploring ways to treat them safely. Overall, few conditions completely rule out immune therapy, and doctors often collaborate across specialties to help patients benefit while managing risks.

CURE recently sat down with Johnson to discuss the safety of immune therapy and challenges that patients with autoimmune disease or organ transplants may face.

Immune therapies, in general, are much better tolerated than some of our traditional cancer treatments, like chemotherapy. So, we are able to treat a broader range of patients than we used to be able to with conventional chemotherapy combinations. There are actually very few absolute contraindications, as I would call them.

So, there are very few things that would completely prevent a patient from receiving immune therapy. However, a few factors that I consider might make treatment more challenging would be significantly impaired functional status. By that, I mean people who have considerable difficulty even getting up and moving around and performing their normal daily activities. We know that even something like immune therapy can be very hard on those patients, and they are also very unlikely to benefit. Patients with very severe autoimmune diseases can also be very challenging, but the vast majority of patients with autoimmune diseases can still receive treatment.

Often, we will co-manage these patients with their rheumatologist, neurologist, or whichever specialist is caring for their autoimmune disease. We may need to adjust some of their regimen slightly and treat them with other medications that partially block the immune system to tamp it down just a bit. But generally speaking, patients with heart problems, lung problems, or kidney problems can receive immune therapy. We just need to monitor them a bit more closely.

I will say that one other area that is certainly under research and that we are concerned about is giving immune therapy to our patients who have had organ transplants. So, if someone has had a liver transplant or a kidney transplant, those patients are at risk of rejecting their organ. There are some new studies that have recently suggested ways they might be able to be treated with pulses of steroids and similar approaches. It seems they can do okay, but that is certainly an area we are just beginning to understand.

Immune therapy is generally safer than chemotherapy, allowing more patients with melanoma and other conditions like heart or lung issues receive treatment.

The advantages and disadvantages of CAR-T cell therapy should be carefully thought about for patients with melanoma.

Addressing Pros and Cons of CAR-T Cell Therapy in Melanoma

For patients with melanoma, treatment with CAR-T cell therapy may come along with pros and cons to consider.

T-cells are immune cells that recognize and destroy foreign invaders in our bodies. CAR-T cell therapy harnesses this power by removing the body's germ-fighting T cells, engineering them to attack cancer cells, and then infusing them back into the body, as explained by an expert in an interview with CURE®.

CURE® interviewed Dr. Anusha Kalbasi, an associate professor of Radiation Oncology at the Stanford School of Medicine, to gain insights into the usefulness and drawbacks of CAR-T cell therapy.

Some patients have an immune system that naturally is ready to attack the cancer, and some drugs or some other treatments may work, like TIL therapy, may work for those patients. But in patients [whose] body's own immune system isn't finding and killing the cancer, we need to come up with an alternative strategy, and CAR-T cell provides an alternative for those patients. So that's one advantage.

The other thing is CAR-T cells can potentially come in with one treatment and clear tumors and then survive in the body as kind of like security guards. So, the idea that this is a living drug that is, it's not just a drug that you give, and it gets excreted out through the kidney, but it's a drug that stays in your body forever and continues to fight on your behalf.

That's one of the benefits. But there are downsides.

You're injecting large numbers of T-cells into the body. You're genetically modifying the T-cells, so there are some risks potentially associated with that, although those risks are very low, if any, and then when the cells expand to try to fight the cancer, there's a lot of inflammation that happens potentially that can cause side effects, that can be detrimental to the patients.

But we've learned a lot from our experiences in blood cancers and how to manage these side effects. And so, we think we can make CAR-T cells safe and effective.

This transcript was edited for clarity and conciseness.

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CAR-T cell therapy for melanoma involves engineering T-cells to target cancer cells, offering an alternative for patients whose immune systems do not naturally attack cancer. This therapy can potentially clear tumors with a single treatment and remain in the body as a long-term defense. However, the process involves risks such as inflammation and side effects due to the large number of genetically modified T-cells introduced. Despite these challenges, advancements in managing side effects from blood cancer treatments suggest CAR-T cells can be made safe and effective.

An expert explained how a patient’s own T cells can be extracted, manufactured and infused back into the body as a treatment option for melanoma.

TIL Therapy Uses the Body’s Own Cells to Attack Cancer Cells in Melanoma

Tumor-infiltrating lymphocyte (TIL) therapy is a promising new approach to cancer therapy that harnesses the body’s own immune system to treat diseases like melanoma, a type of skin disease, an expert said.

In February 2024, Amtagvi (lifileucel) was the first 

 to treat patients with advanced melanoma whose disease progressed on or after anti-PD-1/PD-L1 therapy and targeted therapy. With TIL therapy, T cells are extracted from a patient’s tumor, grown in a lab and then reinfused back into the patient to attack cancer cells.

As research progresses, TIL therapy may become a more accessible and effective treatment for other cancers.

CURE® spoke with Dr. Goran Micevic, assistant professor of dermatology and dermatopathology at Yale and member of the Yale Cancer Center, to learn more about TIL therapy and how the science behind it.

TIL therapy is kind of a new old therapy because the concept behind TIL therapies has been around for several decades really. It's been spearheaded at the surgery branch at the National Cancer Institute by Dr. Steven Rosenberg.

But the basic idea is that you take T cells, which are, you know, immune cells that can recognize foreign threats from the patient, you expand them outside of the patient's body and then you reinfuse them in an effort to battle cancer.

And so this is kind of a live therapy, as opposed to chemotherapies, which are chemicals and molecules, and as opposed to immune therapies, which we've kind of [been] witnessing the revolution [of], which are still molecules. So these are live cells, and they're the patient's own cells.

And it is a fairly complex therapy, and it's gone over several iterations, and usually is available only in an inpatient setting, or at least has been so far. And the reason for that is that when you infuse somebody with their own T cells, there's a lot of preparatory work that you need to do. So it's not unlike a bone marrow transplant. It's very involved really. So you have to prepare the patient and essentially immunosuppress them.

So you give them a lymphoablative therapy over a period of about a week prior to them receiving their own cells, and then when they receive the cells, you still have to receive what we call interleukin-2, high-dose interleukin-2, which is a chemical that actually activates T cells to kind of wake them up from their slumber. But you know that treatment also induces some unpleasant symptoms which are not unlike an inflammatory condition called sepsis.

Tumor-infiltrating lymphocyte (TIL) therapy represents a novel immunotherapy approach, utilizing the patient's own T cells to combat cancer, particularly advanced melanoma. In February 2024, Amtagvi (lifileucel) became the first FDA-approved TIL therapy for melanoma patients unresponsive to prior treatments. The process involves extracting T cells from tumors, expanding them in vitro, and reinfusing them into the patient. Despite its complexity and inpatient requirement, TIL therapy holds promise for broader cancer applications as research advances.

Patients with resectable stage 3 melanoma should talk about pretreatment therapy with their cancer care teams, an expert said.

Patients With Stage 3 Melanoma Should Discuss Adjuvant Therapy

Patients with resectable stage 3 melanoma should be talking with their care teams about presurgical (adjuvant) therapy, according to Dr. Georgina V. Long.

“[For] any patient who comes in with resectable stage 3 melanoma that's clinically detectable, They need to be talking to their physicians, their doctors, about neoadjuvant treatment — particularly neoadjuvant immunotherapy,” Long said during an interview at the 2024 

American Society of Clinical Oncology (ASCO) Annual Meeting

Long is the chair of melanoma medical oncology and translational research, at The University of Sydney in Australia. At the 2024 ASCO meeting, she presented long-term follow-up data from the 

. The trial analyzed Tafinlar (dabrafenib) plus Mekinist (trametinib) for this patient population, and showed that at the eight-year mark, 71% of patients on the drug duo were still alive, compared to 65% who were given a placebo.

Further, Tafinlar plus Mekinist showed no new safety concerns that were not previously reported, and there were no irreversible side effects.

“The great thing about [Tafinlar] and [Mekinist] is the toxicities are reversible,” Long said.

Tafinlar and Mekinist are targeted therapies that work by blocking certain proteins that are essential in cancer cell growth, according to the Melanoma Research Alliance. The 

drug combination was approved in April 2018

 based on earlier findings from the COMBI-AD trial.

[For] any patient who comes in with resectable stage 3 melanoma that's clinically detectable, They need to be talking to their physicians, their doctors, about neoadjuvant treatment — particularly neoadjuvant immunotherapy.

Patients with lower risk or not clinically detectable stage 3 melanoma then they need to discuss with their physicians, adjuvant treatment and that is where the discussion of the [Tafinlar] and [Mekinist] versus the other available adjuvant treatments occurred. The great thing about [Tafinlar] and [Mekinist] is the toxicities are reversible.

Conference

What advice do you have for patients and caregivers of those recently diagnosed with uveal melanoma?

Because metastatic uveal melanoma is so rare, it’s very important that patients seek a provider who’s familiar with the treatment landscape.One of the other things patients with uveal melanoma can do when they’re first diagnosed is seek out information provided by patient advocacy organizations.

Now that Kimmtrak [tebentafusp] has been approved for metastatic uveal melanoma, it has really brought to light a lot of the differences between uveal melanoma and skin melanoma, and the need for additional treatments. Specifically, there’s a huge unmet need that remains for patients who are HLA-A*02:01 negative. I’m happy to say that there are a number of ongoing clinical trials looking at new treatment options. Having an FDA-approved therapy has also brought greater awareness to this rare melanoma subtype.

Thank you for joining me to learn about uveal melanoma. We hope you found this 

Marlana M. Orloff, MD, offers advice for patients who are diagnosed with metastatic uveal melanoma.

Advice for Patients Diagnosed with Metastatic Uveal Melanoma

How is Kimmtrak administered? What can patients expect from treatment? How are adverse events managed?

Kimmtrak [tebentafusp] is a weekly IV [intravenous] infusion. Due to the risk of side effects, specifically cytokine release syndrome, the first three doses have to be given in an extended monitored setting where patients are observed for at least 16 hours. During this time, the patient’s vital signs are monitored very closely as there is a risk for low blood pressure, high fever, and low oxygen. Should these occur, patients are managed appropriately, sometimes with things like IV fluids, medication to get the fever down, and in some scenarios, if severe enough, they may require steroids.

For the majority of patients, adverse effects peak during the first three doses, and after the third dose, patients can be safely transitioned to receive their infusion as an outpatient. Most patients following those first three doses do not experience significant adverse effects. One of the more long-term side effects we see for patients who’ve been on tebentafusp for a long time can be things such as whitening of the hair, eyebrows, eyelashes, and skin, which is called vitiligo.

An expert on uveal melanoma reviews the treatment protocol for tebentafusp, which is approved for the treatment of metastatic disease.

Tebentafusp Treatment Protocol in Metastatic Uveal Melanoma

For patients who are eligible for treatment with Kimmtrak, how does this treatment work?

Kimmtrak [tebentafusp] is a newer type of immunotherapy, also called a T-cell redirector, that acts like a magnet that combines your own immune system, your T cell, and drags it over to a target on the cancer, something called gp100 [glycoprotein 100], and kind of forces them to engage, hopefully allowing the immune system to kill the cancer.

In the clinical trial, they compared Kimmtrak to investigator’s choice, which could have been pembrolizumab, dacarbazine, or ipilimumab. Kimmtrak showed a 1-year overall survival of 73% vs 59% in the comparator group. It was this improvement in overall survival that led to the FDA approval of Kimmtrak.

Due to Kimmtrak’s unique mechanism of action, one of the most common adverse effects we can see is rash. The drug can drag the immune system over to something called gp100, which is on the surface of the tumor but also on melanocytes in the skin causing the rash. One of the other adverse effects that we need to monitor patients very carefully for is something called cytokine release syndrome. This type of syndrome is really due to immune overstimulation, and we can see things such as fever, low blood pressure, and low oxygen. It’s very important that these patients are monitored, at least for the first 16 hours, for the first three doses, to ensure that this syndrome, if it does occur, is managed appropriately.

Marlana M. Orloff, MD, discusses key efficacy data and reviews adverse events seen with tebentafusp in patients with metastatic uveal melanoma.

Melanoma

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