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PARP Inhibitor
SBRT + Olaparib and Pembrolizumab + Olaparib for Gastric Cancer
Phase 2
Recruiting
Led By Sunnie S Kim, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be ≥ 18 years of age
Participant must have at least one radiographically-confirmed index lesion that will not undergo RT and is measurable based on RECIST v1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that combines two existing treatments. The first part of the trial is to make sure the treatment is safe, and then they will assess how well it works.
Who is the study for?
Adults with metastatic gastric or gastroesophageal cancer who've had prior treatment including fluoropyrimidine and platinum drugs. They must be able to swallow pills, have good organ function, and a specific gene mutation related to DNA repair. Pregnant women can't join; men and women must agree to contraception.Check my eligibility
What is being tested?
This phase II trial tests if olaparib combined with radiation therapy followed by olaparib plus pembrolizumab improves outcomes in patients with certain genetic mutations after previous treatments for their advanced stomach cancers.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, skin reactions from radiation, immune-related conditions due to pembrolizumab (like inflammation of organs), blood count changes, and potential allergic reactions to the medications used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have at least one tumor that can be measured and hasn't been treated with radiation.
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I have a mutation in a gene linked to DNA repair.
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My stomach cancer is confirmed and can be biopsied.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) of unirradiated tumors
Secondary outcome measures
Disease Control Rate (DCR) of Total Cohort and HRD (Homologous Recombination Deficiency) versus HR (Homologous Recombination) proficient.
Duration of Response (DOR) of Total Cohort and HRD (Homologous Recombination Deficiency) versus HR (Homologous Recombination) proficient.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 during concurrent SBRT/olaparib
+2 moreSide effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: HR proficient cohortExperimental Treatment3 Interventions
No identifiable somatic or germline deleterious mutation in DNA Response and Repair pathway
Group II: HR deficient cohortExperimental Treatment3 Interventions
Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,645 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,500 Total Patients Enrolled
Sunnie S Kim, MDPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to have tumor biopsies during the study, but I understand I can stay in the study even if later biopsies are not possible.You are able to read and sign the consent form indicating that you agree to participate in the study.My stomach cancer is confirmed and can be biopsied.I have had NGS testing to determine my treatment group.My organs are functioning well.I agree to have tumor biopsies during the study, but I understand exceptions may apply.My test shows a specific gene mutation affecting DNA repair.I've had treatment with fluoropyrimidine, platinum, and if HER2+, trastuzumab.I have an autoimmune disease treated with medication in the last 2 years.I have been diagnosed with HIV.I am 18 years old or older.My cancer is in a place where it can be treated with radiation.I have had NGS testing to determine my treatment group.I have not had any cancer treatment or experimental drugs in the last 4 weeks.I have at least one tumor that can be measured and hasn't been treated with radiation.I have another cancer that is getting worse or was treated in the last 3 years.I had radiotherapy over 2 weeks ago and have recovered from side effects without needing steroids.I have had pneumonitis treated with steroids or have it now.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My stomach and intestines absorb medications normally.My brain metastases are stable, and I haven't needed steroids for 14 days.I have not received a live vaccine in the last 30 days.I have a mutation in a gene linked to DNA repair.My stomach cancer is confirmed and can be biopsied.I am currently being treated for an infection.I have a known harmful genetic mutation but don't need retesting for this study.I am fully active or restricted in physically strenuous activity but can do light work.I can swallow pills and liquids without difficulty.I have a tumor in an area that can be treated with radiation, not planned for biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: HR proficient cohort
- Group 2: HR deficient cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the safeness profile of Olaparib for those undergoing treatment?
"Olaparib is believed to be moderately safe, and thus earned a score of 2. This assessment was made given that the drug has yet to pass efficacy testing though there is some evidence corroborating its safety profile."
Answered by AI
Does this research endeavor permit those aged thirty and above to participate?
"As per the requirements of this clinical trial, individuals must be aged 18 or older but no more than 100 years old."
Answered by AI
Who are the ideal candidates for this trial?
"This clinical trial is enrolling 26 individuals aged 18 to 100 suffering from gastroesophageal cancer. In order for patients to be eligible, they must meet the following requirements: being of legal age; having a primary tumor or an isolated metastatic site amenable to radiation in their stomach, esophagus, liver, lungs, pancreas thoracic/abdominal lymph nodes or soft tissues (biopsied sites should not be radiated); undergoing NGS testing at a CLIA certified laboratory with CAP tested and bioinformatics-validated protocols prior starting treatment; signing and dating the consent form; possessing one"
Answered by AI
Is there currently any opportunity to enroll in this clinical trial?
"According to its clinicaltrials.gov page, this trial has closed recruitment as of May 19th 2022. However, there are still 643 other trials actively searching for candidates at the present moment."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
65+
What site did they apply to?
University of Colorado Health
What portion of applicants met pre-screening criteria?
Met criteria
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