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Anti-metabolites

Tisotumab Vedotin vs Chemotherapy for Cervical Cancer (innovaTV 301 Trial)

Phase 3
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology
Has ECOG performance status of 0 or 1 prior to randomization.
Must not have
Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above.
Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization until date of confirmed cr or pr (maximum up to 25 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is to see if tisotumab vedotin is better than chemotherapy to treat cervical cancer.

Who is the study for?
This trial is for individuals with cervical cancer that has returned or spread, who have already tried certain standard treatments without success. They should have had one or two previous treatments for their condition and must be in a relatively good physical state (able to perform daily activities without significant limitations). People with serious eye conditions, bleeding risks, recent major surgery, severe nerve damage, or those who've taken drugs containing MMAE are not eligible.
What is being tested?
The study compares the effectiveness of tisotumab vedotin against traditional chemotherapy drugs (topotecan, vinorelbine, gemcitabine, irinotecan, pemetrexed) in treating recurrent or metastatic cervical cancer. Participants will be randomly assigned to receive either tisotumab vedotin or their choice of one of the chemotherapy drugs.
What are the potential side effects?
Tisotumab vedotin may cause side effects such as fatigue, hair loss, nausea and numbness in hands and feet. Chemotherapy can lead to similar side effects including mouth sores and increased risk of infection due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cervical cancer has returned or spread and is of a specific cell type.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer is not neuroendocrine, lymphoid, sarcomatoid, or any other type not listed in the criteria.
Select...
I have never been treated with drugs containing MMAE.
Select...
I have not had major surgery in the last 4 weeks or minor surgery in the last 7 days.
Select...
I have moderate to severe numbness, tingling, or pain in my hands or feet.
Select...
I have a history of severe eye inflammation or specific eye diseases, but not just cataracts.
Select...
I have a condition or history that increases my risk of serious bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization until date of confirmed cr or pr (maximum up to 25 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until date of confirmed cr or pr (maximum up to 25 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Confirmed Objective Response Rate (ORR) as Assessed by Investigator
Duration of Response (DOR) by Investigator Assessment
EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores
+6 more

Side effects data

From 2022 Phase 2 trial • 102 Patients • NCT03438396
41%
Nausea
39%
Alopecia
39%
Epistaxis
35%
Fatigue
33%
Anaemia
31%
Conjunctivitis
25%
Diarrhoea
25%
Dry eye
20%
Constipation
19%
Peripheral sensory neuropathy
18%
Asthenia
18%
Decreased appetite
17%
Vomiting
17%
Arthralgia
17%
Myalgia
15%
Pyrexia
14%
Rash
14%
Pruritus
14%
Weight decreased
13%
Abdominal pain
13%
Pain in extremity
11%
Keratitis
10%
Urinary tract infection
10%
Vaginal haemorrhage
10%
Insomnia
9%
Cough
9%
Haematuria
8%
Dry mouth
8%
Headache
8%
Back pain
8%
Oedema peripheral
7%
Influenza like illness
7%
Blepharitis
7%
Nasopharyngitis
7%
Musculoskeletal pain
6%
Abdominal pain upper
6%
Punctate keratitis
6%
Rhinorrhoea
6%
Hypomagnesaemia
6%
Upper respiratory tract infection
6%
Rash maculo-papular
6%
Hypokalaemia
5%
Dyspnoea
5%
Anxiety
5%
Dysuria
5%
Hot flush
5%
Erythema
5%
Bone pain
4%
Muscle spasms
4%
Ulcerative keratitis
4%
Ocular hyperaemia
4%
Lacrimation increased
4%
Neutropenia
4%
Peripheral sensorimotor neuropathy
4%
Paraesthesia
4%
Dehydration
4%
Depression
4%
Nasal dryness
4%
Dysgeusia
4%
Dizziness
4%
Burning sensation
4%
Hypocalcaemia
4%
Vaginal discharge
4%
Pneumonia
3%
Venous thrombosis limb
3%
Neuropathy peripheral
3%
Dyspepsia
3%
Rectal haemorrhage
3%
Stomatitis
3%
Chills
3%
Pain
3%
Dry skin
3%
Hyperhidrosis
3%
Cystitis
3%
Vision blurred
3%
Meibomianitis
3%
Eye discharge
3%
Entropion
3%
Iron deficiency anaemia
3%
Oropharyngeal pain
3%
Hypoaesthesia
3%
Neutrophil count decreased
3%
Activated partial thromboplastin time prolonged
3%
Pelvic pain
3%
Flank pain
3%
Lymphoedema
3%
Rhinitis
3%
Nasal congestion
3%
Peripheral motor neuropathy
3%
Hyperglycaemia
3%
Hypertransaminasaemia
2%
Hypertension
2%
Ileus
2%
Urinary tract obstruction
2%
Gingival bleeding
2%
Haemorrhoids
2%
Limb discomfort
2%
Cataract
2%
Conjunctival haemorrhage
2%
Dysphonia
2%
Corneal erosion
2%
Conjunctival hyperaemia
2%
Sinus congestion
2%
Pulmonary embolism
2%
Neuralgia
2%
Platelet count decreased
2%
Lymphocyte count decreased
2%
Hypercreatininaemia
2%
Urinary incontinence
2%
Renal failure
2%
Vertigo
2%
Sinus tachycardia
2%
Contusion
2%
Pneumonitis
2%
Polyneuropathy
2%
Septic shock
2%
Gastritis
2%
Haematochezia
2%
Vaginal infection
2%
Blood creatinine increased
2%
Hypothyroidism
2%
Muscular weakness
2%
Hyperuricaemia
2%
Death
2%
Abdominal distension
2%
Trichiasis
2%
International normalised ratio increased
2%
Electrocardiogram QT prolonged
2%
Blood creatine phosphokinase increased
1%
Chest pain
1%
Neutropenic sepsis
1%
Respiratory tract infection
1%
Urosepsis
1%
Intestinal obstruction
1%
Large intestinal obstruction
1%
Non-cardiac chest pain
1%
Acute kidney injury
1%
Cystitis haemorrhagic
1%
Pleural effusion
1%
Foot fracture
1%
Post-traumatic pain
1%
Thoracic vertebral fracture
1%
Fistula discharge
1%
Bladder cancer
1%
Cancer pain
1%
General physical condition abnormal
1%
Ulcerative Keratitis
1%
Anal haemorrhage
1%
Anal incontinence
1%
Dyschezia
1%
Enteritis
1%
Flatulence
1%
Hiatus hernia
1%
Large intestinal haemorrhage
1%
Lower gastrointestinal haemorrhage
1%
Oesophagitis
1%
Retching
1%
Small intestinal stenosis
1%
Subileus
1%
Face oedema
1%
Chest discomfort
1%
Facial pain
1%
Gait disturbance
1%
Infusion site coldness
1%
Localised oedema
1%
Malaise
1%
Mucosal disorder
1%
Nodule
1%
Oedema
1%
Pain of skin
1%
Skin discolouration
1%
Skin hyperpigmentation
1%
Abscess limb
1%
Bronchitis
1%
Catheter site infection
1%
Clostridium difficile colitis
1%
Corona virus infection
1%
Device related infection
1%
Diverticulitis
1%
Folliculitis
1%
Gastroenteritis
1%
Herpes ophthalmic
1%
Herpes zoster oticus
1%
Stenotrophomonas infection
1%
Tooth abscess
1%
Urinary tract infection bacterial
1%
Hypercreatinaemia
1%
Joint stiffness
1%
Musculoskeletal chest pain
1%
Blepharospasm
1%
Chalazion
1%
Conjunctival erosion
1%
Nasal obstruction
1%
Haemoptysis
1%
Ocular hypertension
1%
Noninfective conjunctivitis
1%
Meibomian gland dysfunction
1%
Keratopathy
1%
Eye pruritus
1%
Eye pain
1%
Eye movement disorder
1%
Eye irritation
1%
Eye inflammation
1%
Corneal scar
1%
Corneal bleeding
1%
Leukopenia
1%
Leukocytosis
1%
Sensory loss
1%
Sciatica
1%
Pulmonary oedema
1%
Paranasal sinus discomfort
1%
Paranasal sinus haemorrhage
1%
Hypercalcaemia
1%
Diabetes mellitus
1%
Ejection fraction decreased
1%
C-reactive protein increased
1%
Blood potassium decreased
1%
Alanine aminotransferase increased
1%
White blood cell count decreased
1%
Creatinine renal clearance decreased
1%
Urinary tract disorder
1%
Urinary bladder haemorrhage
1%
Ureteric obstruction
1%
Hydronephrosis
1%
Chromaturia
1%
Bladder outlet obstruction
1%
Metrorrhagia
1%
Genital swelling
1%
Genital prolapse
1%
Cystocele
1%
Acoustic neuroma
1%
Allergy to metals
1%
Hyperthyroidism
1%
Tinnitus
1%
Myocardial infarction
1%
Tumour pain
1%
Deep vein thrombosis
1%
Aortic thrombosis
1%
Urinary tract stoma complication
1%
Thermal burn
1%
Spinal compression fracture
1%
Radiation proctitis
1%
Radiation associated haemorrhage
1%
Procedural pain
1%
Post procedural haemorrhage
1%
Ligament sprain
1%
Conjunctival scar
1%
Conjunctival abrasion
1%
Gastrooesophageal reflux disease
1%
Small intestinal obstruction
1%
Mouth ulceration
1%
Mucosal inflammation
1%
Peripheral swelling
1%
Thirst
1%
Dermatitis acneiform
1%
Dermatitis allergic
1%
Eczema
1%
Rash macular
1%
Groin pain
1%
Hyponatraemia
1%
Thrombocytosis
1%
Thrombocytopenia
1%
Thrombosis
1%
Hypotension
1%
Herpes zoster
1%
Foreign body sensation in eyes
1%
Cellulitis
1%
Infection
1%
Lower respiratory tract infection
1%
Infusion site extravasation
1%
Abdominal discomfort
1%
Abdominal pain lower
1%
Colitis
1%
Duodenogastric reflux
1%
Genital herpes
1%
Gingivitis
1%
Parotitis
1%
Pharyngitis streptococcal
1%
Musculoskeletal discomfort
1%
Neck pain
1%
Osteoarthritis
1%
Amblyopia
1%
Asthenopia
1%
Retinal exudates
1%
Photophobia
1%
Sneezing
1%
Hyperaesthesia
1%
Weight increased
1%
Prothrombin time prolonged
1%
Hypoalbuminaemia
1%
Hypernatraemia
1%
Blood bicarbonate decreased
1%
Blood alkaline phosphatase increased
1%
Aspartate aminotransferase increased
1%
Depressed mood
1%
Vulvovaginal pain
1%
Vaginal ulceration
1%
Vaginal fistula
1%
Rectocele
1%
Hyperbilirubinaemia
1%
Stress cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tisotumab Vedotin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tisotumab vedotinExperimental Treatment1 Intervention
Tisotumab vedotin monotherapy
Group II: ChemotherapyActive Control5 Interventions
Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tisotumab vedotin
2018
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

GenmabIndustry Sponsor
71 Previous Clinical Trials
14,419 Total Patients Enrolled
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
73,836 Total Patients Enrolled
Shweta Jain, MDStudy DirectorSeagen Inc.
Leo NicacioStudy DirectorSeagen Inc.
Medical MonitorStudy DirectorSeagen Inc.
1,678 Previous Clinical Trials
989,793 Total Patients Enrolled
Sonia Deutsch, MDStudy DirectorSeagen Inc.
Leo Nicacio, MDStudy DirectorSeagen Inc.
Liz Whalley, PhDStudy DirectorSeagen Inc.

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04697628 — Phase 3
Cervical Cancer Research Study Groups: Tisotumab vedotin, Chemotherapy
Cervical Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04697628 — Phase 3
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04697628 — Phase 3
~106 spots leftby Dec 2025
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