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Monoclonal Antibodies
Avelumab + Berzosertib for Advanced Cancer
Phase 1 & 2
Waitlist Available
Led By Timothy A Yap
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 2 X ULN or estimated creatinine clearance >= 30 mL/min
Subjects with germline defects in DDR genes are eligible for this trial
Must not have
Major surgery within 4 weeks prior to study enrollment
Known additional malignancy that is active and/or progressive requiring treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying avelumab and M6620 to see how well they work in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body and have a deficiency in their ability to repair damaged DNA.
Who is the study for?
This trial is for adults with solid tumors that have spread or can't be surgically removed, and are not responding to standard treatments. Participants must have a certain level of physical fitness (ECOG 0-1), adequate organ function, and no severe allergies to study drugs. They should also agree to use effective contraception if applicable.
What is being tested?
The trial is testing the combination of Avelumab, an immunotherapy drug, with M6620 in patients whose tumors show DNA repair deficiencies. It aims to find the safest dose and see how well these drugs work together against advanced cancers.
What are the potential side effects?
Potential side effects may include immune-related reactions like inflammation in various organs, infusion-related symptoms, fatigue, changes in blood counts which could affect infection risk or cause bleeding issues, liver or kidney function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range.
Select...
I have a genetic defect in DNA repair genes.
Select...
I've tried all treatments for my condition without success or couldn't tolerate them.
Select...
My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
Select...
My cancer has spread, cannot be surgically removed, and standard treatments are not effective.
Select...
I have received treatment for cancer that has spread.
Select...
My cancer has specific genetic changes that can be targeted with treatment.
Select...
I am fully active or can carry out light work.
Select...
I am fully active or can carry out light work.
Select...
I have a genetic defect in DNA repair genes.
Select...
I have tried or cannot tolerate all known beneficial treatments and haven't refused any available therapies.
Select...
I am not pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery in the last 4 weeks.
Select...
I have another cancer that is growing and needs treatment.
Select...
I haven't had cancer treatment or radiation in the last 4 weeks.
Select...
I am not on immunosuppressive drugs, except for allowed steroids.
Select...
I am not on strong CYP3A4 inhibitors or inducers that can't be stopped.
Select...
I am not pregnant or breastfeeding and willing to use two effective birth control methods.
Select...
I have a serious heart condition.
Select...
I have a history of immune-related bowel or lung conditions.
Select...
I have lasting side effects from previous treatments that are moderate or worse.
Select...
I have been diagnosed with myelodysplastic syndrome.
Select...
I have had an organ or stem cell transplant.
Select...
I am currently on medication for an infection.
Select...
I need steroids for my brain metastases symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Arm A)
Incidence of dose limiting toxicities (DLTs) (Arm A)
Secondary study objectives
Clinical benefit rate
Overall survival (OS)
Progression free survival (PFS)
+1 moreSide effects data
From 2023 Phase 2 trial • 76 Patients • NCT0476829666%
Anaemia
36%
Thrombocytopenia
32%
Neutropenia
30%
Platelet count decreased
27%
Nausea
25%
Decreased appetite
25%
Asthenia
18%
White blood cell count decreased
18%
Constipation
16%
Neutrophil count decreased
15%
Dyspnoea
15%
Diarrhoea
14%
Vomiting
14%
Fatigue
12%
Lymphocyte count decreased
11%
Hypokalaemia
11%
Pneumonia
10%
Hypoalbuminaemia
10%
Headache
10%
Alanine aminotransferase increased
10%
Aspartate aminotransferase increased
10%
Cough
8%
Weight decreased
8%
Epistaxis
8%
Blood alkaline phosphatase increased
8%
Lipase increased
8%
Hypocalcaemia
7%
Hyponatraemia
7%
Pyrexia
7%
Insomnia
7%
Dizziness
5%
Haemoptysis
5%
Malaise
5%
Mucosal inflammation
5%
Hypomagnesaemia
5%
Gamma-glutamyltransferase increased
5%
Hyperglycaemia
5%
Febrile neutropenia
5%
COVID-19
5%
Hypertension
4%
Gastrooesophageal reflux disease
4%
Liver injury
4%
Dyspnoea exertional
4%
Oedema peripheral
4%
Alopecia
4%
COVID-19 pneumonia
4%
Tachycardia
4%
Abdominal pain
4%
Blood creatinine increased
4%
Hypophosphataemia
4%
Dysgeusia
3%
Haemoglobin decreased
3%
Productive cough
3%
Blood bilirubin increased
3%
Pleural effusion
3%
Localised oedema
3%
Night sweats
3%
Blood magnesium decreased
3%
Neuropathy peripheral
3%
Pruritus
3%
Chest discomfort
3%
Paraesthesia
3%
Pain
3%
Anxiety
3%
Sepsis
3%
Leukopenia
3%
Atrial fibrillation
3%
Abdominal pain upper
3%
Chills
3%
Upper respiratory tract infection
3%
Activated partial thromboplastin time prolonged
3%
Amylase increased
3%
Blood albumin decreased
3%
Blood lactate dehydrogenase increased
3%
Arthralgia
3%
Back pain
3%
Muscle spasms
3%
Dysphonia
3%
Hypotension
3%
Pallor
1%
Metastases to central nervous system
1%
Photosensitivity reaction
1%
Creatinine renal clearance decreased
1%
Hepatic pain
1%
Memory impairment
1%
Acute kidney injury
1%
Decubitus ulcer
1%
Pleuritic pain
1%
Blood sodium decreased
1%
Tremor
1%
Gout
1%
Presyncope
1%
Seizure
1%
Pneumonia bacterial
1%
Blood urea increased
1%
Hemiparesis
1%
Device malfunction
1%
Skin lesion
1%
Hypoglycaemia
1%
Lip dry
1%
Herpes zoster reactivation
1%
Cholestasis
1%
Wound infection
1%
Influenza like illness
1%
Conjunctival pallor
1%
Diplopia
1%
Haemorrhoids
1%
Generalised oedema
1%
Injection site pruritus
1%
Electrocardiogram QT prolonged
1%
Rash
1%
Blood phosphorus decreased
1%
C-reactive protein increased
1%
CD4/CD8 ratio decreased
1%
Hypochloraemia
1%
Depression
1%
Dyspnoea paroxysmal nocturnal
1%
Rash pruritic
1%
Secretion discharge
1%
Hyperthermia
1%
Choluria
1%
Swelling face
1%
Hyperbilirubinaemia
1%
Respiratory tract infection
1%
Nail disorder
1%
Haemorrhoids thrombosed
1%
Hyperkalaemia
1%
Transient aphasia
1%
Sinusitis
1%
Confusional state
1%
Electrolyte imbalance
1%
Pneumonia pneumococcal
1%
Eye discharge
1%
Gingival pain
1%
Sputum discoloured
1%
Oral disorder
1%
Wheezing
1%
Hypoxia
1%
Pneumothorax
1%
Lower gastrointestinal haemorrhage
1%
Pulmonary embolism
1%
Petechiae
1%
Tooth loss
1%
Spinal compression fracture
1%
Cancer pain
1%
Hemianopia homonymous
1%
Nasal congestion
1%
Myelosuppression
1%
Acute coronary syndrome
1%
Vestibular disorder
1%
Disease progression
1%
General physical health deterioration
1%
Multiple organ dysfunction syndrome
1%
Enterococcal sepsis
1%
Lung abscess
1%
Septic shock
1%
Serratia sepsis
1%
Staphylococcal sepsis
1%
Urinary tract infection
1%
Urosepsis
1%
Acute respiratory distress syndrome
1%
Respiratory failure
1%
Coagulopathy
1%
Thrombocytosis
1%
Arrhythmia
1%
Cardiac failure
1%
Sinus tachycardia
1%
Hypothyroidism
1%
Immune-mediated hypothyroidism
1%
Macular oedema
1%
Abdominal discomfort
1%
Abdominal distension
1%
Dry mouth
1%
Dyspepsia
1%
Dysphagia
1%
Flatulence
1%
Chest pain
1%
Face oedema
1%
Gait disturbance
1%
Hypersensitivity
1%
Bronchiolitis
1%
Bronchitis
1%
Candida infection
1%
Diverticulitis
1%
Gastroenteritis
1%
Compression fracture
1%
Fall
1%
Radiation oesophagitis
1%
Radiation pneumonitis
1%
Spinal fracture
1%
Aspartate aminotransferase decreased
1%
Blood cholesterol increased
1%
Blood glucose increased
1%
Blood lactic acid increased
1%
Platelet count increased
1%
Urine output decreased
1%
Malnutrition
1%
Muscular weakness
1%
Pain in extremity
1%
Tumour pain
1%
Disturbance in attention
1%
Nephrolithiasis
1%
Renal impairment
1%
Aphonia
1%
Deep vein thrombosis
1%
Orthostatic hypotension
1%
Phlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety run-in Part (DL2) + Main Part: Berzosertib 210 mg/m^2 + Topotecan 1.25 mg/m^2
Safety run-in Part (Dose Level 1 [DL 1]): Berzosertib 105 mg/m^2 + Topotecan 1.25 mg/m^2
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (avelumab, M6620)Experimental Treatment2 Interventions
Patients receive avelumab IV over 60 minutes on days 1 and 15, and M6620 IV over 60 minutes on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2017
Completed Phase 2
~2440
Berzosertib
2021
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,520 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
508 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is within the required range.I have not had major surgery in the last 4 weeks.I am using effective birth control methods.I have another cancer that is growing and needs treatment.I haven't had cancer treatment or radiation in the last 4 weeks.You are expected to live for at least 12 more weeks.I am not on immunosuppressive drugs, except for allowed steroids.I am not on strong CYP3A4 inhibitors or inducers that can't be stopped.I am HIV positive and meet all the trial's requirements.I have a genetic defect in DNA repair genes.I am not pregnant or breastfeeding and willing to use two effective birth control methods.I've tried all treatments for my condition without success or couldn't tolerate them.My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.My cancer has spread, cannot be surgically removed, and standard treatments are not effective.I have received treatment for cancer that has spread.My cancer has specific genetic changes that can be targeted with treatment.I have a serious heart condition.I am fully active or can carry out light work.I have a history of immune-related bowel or lung conditions.I am fully active or can carry out light work.I do not have any health or mental conditions that could make this study risky for me.I have been treated with immune checkpoint inhibitors before.I have a genetic defect in DNA repair genes.I have lasting side effects from previous treatments that are moderate or worse.I am a woman who cannot become pregnant.I have had at least one treatment for my advanced cancer or there are no known treatments for it.My cancer has a specific gene change that can be targeted for treatment.I have previously been treated with immune checkpoint inhibitors.I must provide a recent tumor sample and agree to a biopsy unless it's too risky.I have tried or cannot tolerate all known beneficial treatments and haven't refused any available therapies.My cancer can be measured by scans or has spread to my bones and can be evaluated.I am experiencing or have had severe side effects from immune checkpoint inhibitors.I have been diagnosed with myelodysplastic syndrome.You have had a serious allergic reaction to the investigational product or any of its ingredients before.I have had an organ or stem cell transplant.I am currently on medication for an infection.I am not pregnant.I need steroids for my brain metastases symptoms.You are expected to live for at least 12 more weeks.I have an autoimmune disease that could worsen with immune-stimulating treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (avelumab, M6620)
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.