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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 to 3 years for reporting.

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 • NCT02019277

70%

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

Lacrimation increased

Febrile neutropenia

Rash pustular

Chills

Anaemia

Oedema peripheral

Oral candidiasis

Sinusitis

Anxiety

Rhinorrhoea

Acne

Erythema

Musculoskeletal chest pain

Injection site reaction

Skin lesion

Conjunctivitis

Nail infection

Chest pain

Tachycardia

Abdominal pain upper

Dry mouth

Dyspepsia

Chest discomfort

Pain

Hypocalcaemia

Bone pain

Depression

Dyspnoea exertional

Dermatitis acneiform

Lymphoedema

Weight decreased

Tooth extraction

Pulmonary embolism

Cellulitis

Device related infection

Gastroenteritis

Wound infection

Femur fracture

Breast cancer

Syncope

Psychotic disorder

Dermatitis bullous

Cardiac failure

Drug hypersensitivity

Gastritis

Dermatomyositis

Oesophagitis

Sepsis

100%

80%

60%

40%

20%

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

~490

Nab-paclitaxel

2014

Completed Phase 3

~1950