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Monoclonal Antibodies
Tumor Treating Fields + Chemotherapy for Cancer
Phase 1
Recruiting
Led By Apostolia Tsimberidou, MD,PHD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety and efficacy of a new cancer treatment involving electrical fields and two different drugs.
Who is the study for?
This trial is for adults with advanced solid tumors in the abdomen or thorax, who are physically able to handle treatment (ECOG 0-1), have a life expectancy over 3 months, and meet certain blood count criteria. They must not be pregnant/breastfeeding, agree to use contraception, and should not have severe medical conditions or allergies that conflict with the treatments.
What is being tested?
The trial tests Tumor Treating Fields Therapy using NovoTTF devices combined with cabozantinib or nab-paclitaxel plus atezolizumab. It aims to find safe doses and see how well these combinations control cancer by disrupting cell division, blocking tumor growth signals, killing cancer cells directly, and boosting immune responses against cancer.
What are the potential side effects?
Possible side effects include skin irritation from device adhesives or hydrogel; reactions related to immunotherapy like inflammation of organs; issues from kinase inhibitors such as high blood pressure; chemotherapy-related nausea, hair loss; fatigue; increased risk of infections due to weakened immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To assess the safety and tolerability of TTF, including the maximum tolerated dose (MTD).
Secondary study objectives
To assess the objective response rate, progression-free survival and overall survival
Side effects data
From 2016 Phase 3 trial • 50 Patients • NCT0201927770%
Diarrhoea
68%
Fatigue
56%
Neuropathy peripheral
54%
Alopecia
52%
Rash
46%
Nausea
38%
Upper respiratory tract infection
36%
Myalgia
34%
Vomiting
34%
Headache
28%
Muscle spasms
24%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Lacrimation increased
8%
Febrile neutropenia
8%
Rash pustular
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Device related infection
2%
Gastroenteritis
2%
Wound infection
2%
Femur fracture
2%
Breast cancer
2%
Syncope
2%
Psychotic disorder
2%
Dermatitis bullous
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 (TFF, atezolizumab, nab-paclitaxel)Experimental Treatment3 Interventions
Patients receive TTF continuously for at least 18 hours per day on days 1-28 of each cycle. Patients also receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 of each cycle and atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Cohort 1 (TTF, cabozantinib)Experimental Treatment2 Interventions
Patients receive TTF continuously for at least 18 hours per day on days 1-21 of each cycle. Patients also receive cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib S-malate
2013
Completed Phase 2
~470
Nab-paclitaxel
2014
Completed Phase 3
~1950
Atezolizumab
2016
Completed Phase 3
~5860
Tumor Treating Fields Therapy
2018
Completed Early Phase 1
~30
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,181 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,425 Total Patients Enrolled
Apostolia Tsimberidou, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My bone marrow is functioning normally.I haven't had cancer treatment or radiation in the last 2 weeks.I have fully recovered from side effects of my previous cancer treatment.I am eligible for the Cabozantinib treatment group.I am 18 years old or older.I am eligible for the Atezolizumab study group.My liver is working well.I have active cancer spread to my brain or its coverings.I do not have any severe or uncontrolled medical conditions.My advanced cancer in the abdomen or chest has worsened despite standard treatments.I have liver cancer with good liver function, no severe fluid in the abdomen, and no risk of serious bleeding or wound issues.I have a heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (TTF, cabozantinib)
- Group 2: Cohort 2 (TFF, atezolizumab, nab-paclitaxel)
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.
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