CLINICAL TRIAL

Olaparib for Melanoma

Metastatic
Refractory
Stage III
Recruiting · 18+ · All Sexes · San Francisco, CA

This study is evaluating whether olaparib in combination with pembrolizumab may be effective in treating patients with advanced, metastatic melanoma.

See full description

About the trial for Melanoma

Eligible Conditions
Melanoma · Metastatic Melanoma

Treatment Groups

This trial involves 2 different treatments. Olaparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pembrolizumab
DRUG
Olaparib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Olaparib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
, TP53 People who have a mutation or alteration in any of the genes listed above, including ARID1A/B, ARID2, ATM, ATR, BARD1, BRCA1/2, BAP1, BRIP1, CHEK2, FANCA, FANCD2, MRN11A, PALB2, RAD50, RAD51, RAD54B, TP53, are at a higher risk for developing cancer. show original
Patients who have a disease which is refractory or resistant to anti PD-1 therapy (defined as disease progression within 6 months after the last dose of anti PD-1 antibody therapy) and, for V600 BRAF mutation, disease must be progressed after BRAF inhibitor therapy; or patients could not have tolerated the standard therapies, are eligible for the study. show original
The patient must have an ECOG performance status of 0 to 1, indicating that they are in good or normal health. show original
You can have up to one previous systemic cytotoxic therapy regimen; there is no limit on the number of prior immunotherapy or targeted therapy regimens. show original
The patient must have recovered from all adverse events (AEs) due to previous therapies to a grade of 1 or lower or to their baseline. show original
The patient must have measurable disease according to RECIST 1.1. show original
A diagnosis of melanoma that is stage III or IV and cannot be surgically removed or has spread to other parts of the body. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Olaparib will improve 1 primary outcome and 3 secondary outcomes in patients with Melanoma. Measurement will happen over the course of 6 months.

Objective Response Rate (ORR)
6 MONTHS
ORR of olaparib in combination with pembrolizumab in patients with advanced melanoma with genetic homologous recombination (HR) mutation/ alteration using RECIST v1.1
6 MONTHS
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
2 YEARS
Evaluation of the safety profile of olaparib in combination with pembrolizumab in patients with advanced melanoma with genetic homologous recombination (HR) mutation/ alteration
2 YEARS
Overall survival (OS)
2 YEARS
OS of patients with advanced melanoma with genetic HR mutation/ alteration who are treated with olaparib in combination with pembrolizumab
2 YEARS
Progression-free survival (PFS)
2 YEARS
PFS of patients with advanced melanoma with genetic HR mutation/ alteration who are treated with olaparib in combination with pembrolizumab
2 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for melanoma?

All treatments of melanoma involve surgical and/or non Surgical modalities. Although most of these modalities are used as adjuvant therapy, they may also be used as monotherapy. It is important to note the high rate of relapse even with surgical therapies and aggressive chemotherapy, suggesting a potential contribution of adjuvant chemotherapeutic treatments. It is also important to note the high morbidity and mortality of melanoma, even with curative treatment. It is, as a result, critical to understand what, if any, adjuvant treatments are beneficial to offer. Understanding treatments is important in deciding for appropriate clinical trials, and selecting patients for adjuvant therapy.

Anonymous Patient Answer

How many people get melanoma a year in the United States?

Melanoma is the 11th most common cancer in the United States and affects about 11,200 adults, or 0.3% of the US adult population each year.

Anonymous Patient Answer

Can melanoma be cured?

Data from a recent study emphasizes the role that genetics play in the development of the disease and the lack of effectiveness of treatment to eradicate the tumour. Although no cure exists for melanoma, the results have highlighted the importance of early detection and treatment of the disease.

Anonymous Patient Answer

What causes melanoma?

We found that environmental factors such as sun exposure, sunscreen and a history of freckles all contribute to the development of melanoma. We also found that the increased exposure to sun triggers the development of atypical melanocytic lesions. We also observed that there is a hereditary predisposition to malignant melanoma. Those who are carriers of the atypical nevi will inherit a higher risk of malignant melanoma. However, atypical nevi alone cannot give a person a 10-fold increased risk of developing melanoma later in life.

Anonymous Patient Answer

What are the signs of melanoma?

Melanomas can be suspected in any dark-coloured skin lesion. Those with a history of immunosuppressing condition are at highest risk. Patients with a family history of melanoma should be tested for atypical melanocytic nevi. Skin-directed immunosuppressants such as photodynamic therapy might be considered in high-risk patients with proven melanoma. Melanoma should be excluded in patients with atypical nevi, especially in patients over the age of 50 years. We recommend biopsy of all suspicious dark-coloured lesions, including those of known melanoma. Clinical or radiographic examination cannot reliably exclude melanoma.

Anonymous Patient Answer

What is melanoma?

Melanoma is a type of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) that arises from the melanocytes in the skin. In the USA, it is the eighth most common cancer, and the fourth most costly cancer after prostate, breast and colorectal cancers. In 2006, the American Cancer Society issued its first Melanoma Update Report. This report contains a number of innovations, for example in the staging of the disease.

Anonymous Patient Answer

What are the chances of developing melanoma?

A family physician should not underestimate the risk of developing melanoma. Once a diagnosis is made, an individual family doctor can treat, and that is a crucial part of managing a patient. Once the diagnosis is made, a thorough exam and other tests should be performed, including an ultrasound exam and an eye exam by an ophthalmologist or optometrist. Then the patient is advised to see the family physician again. If the patient hasn’t had any serious illnesses before this, then the main reason for this visit is a complete medical history and physical exam. The patient is asked about their general health, health problems with other family members (particularly relatives who had skin cancer) and any medications that the patient is taking.

Anonymous Patient Answer

What are the latest developments in olaparib for therapeutic use?

A recent phase III, randomized, double-blind trial of olaparib in advanced melanoma patients with no response or progressive disease to licensed agents demonstrated statistically significant benefits for patients treated with olaparib based on the primary endpoint of PFS; in addition, the secondary endpoint of OS, which was defined as the primary endpoint plus OS, was significantly improved with olaparib. Patients with mTOR pathway-pathway-specific mutation should be an option in the management of these patients, although no formal targeted agents are available to treat these patients. Olaparib is a promising drug in terms of its efficacy in patients with advanced melanoma.

Anonymous Patient Answer

What is the survival rate for melanoma?

Survival rate for melanoma has been shown to be dependent on the thickness of the tumor, which inversely correlates with the size of the tumor. Patients' age, gender, and disease stage also play a role in their survival rate. Patients with thinner tumors living longer are more likely to survive.

Anonymous Patient Answer

Is olaparib safe for people?

Because people treated with olaparib have had a significant risk of experiencing serious liver damage, even though such toxicity is considered a rare adverse effect of olaparib, it is necessary to advise the careful use of the medication in daily clinical practice.

Anonymous Patient Answer

What is the latest research for melanoma?

While there are no randomized controlled trials (RCT) specifically aimed at melanoma and many are either too old or too recent, some findings regarding melanoma research are new and need to be further assessed by large prospective trials. In particular, newer studies are needed on the clinical presentation, pathogenesis, and biological features of cutaneous melanoma. While it will take time before adequate clinical trials of investigational melanoma agents are conducted, clinical studies for these agents might help determine the best treatment for patients with melanoma.

Anonymous Patient Answer

Is olaparib typically used in combination with any other treatments?

These data do not permit the detection of any clinical factors that predict a differential response to olaparib monotherapy in combination with any other treatments compared with other AAS.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Melanoma by sharing your contact details with the study coordinator.