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Anti-metabolites

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

Phase 3
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted.
Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent. Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

innovaTV 301 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.Check my eligibility
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.See study design
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.

innovaTV 301 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had 1 or 2 treatments for my returning or spreading cervical cancer, not including initial chemotherapy with surgery or radiation.
Select...
My cancer progressed after receiving standard chemotherapy or treatments.
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.

innovaTV 301 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
Duration of response (DOR) as assessed by the investigator
Health-related quality of life as assessed by EORTC-QLQ-C30
+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

innovaTV 301 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?

Seagen Inc.Lead Sponsor
206 Previous Clinical Trials
68,783 Total Patients Enrolled
GenmabIndustry Sponsor
56 Previous Clinical Trials
11,676 Total Patients Enrolled
Sonia Deutsch, MDStudy 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many hospitals is this research project being conducted?

"Potential participants of this study can go to University of Alberta / Cross Cancer Institute in Edmonton, British Columbia Cancer Agency - Vancouver Centre in Vancouver, Sunnybrook Health Sciences Centre in Toronto, or any of the other five locations."

Answered by AI

Could you please provide a list of similar tisotumab vedotin clinical trials?

"Currently, 985 ongoing clinical trials are investigating tisotumab vedotin. 274 of those active studies are in the third stage of testing. Although many trials for tisotumab vedotin originate from Shanghai, there are a total of 45830 locations running these tests."

Answered by AI

Can anyone receive this treatment, or are there specific requirements?

"Yes, the information on clinicaltrials.gov indicates that this clinical trial is actively looking for patients. The study was initially posted on 2/22/2021 and was last updated on 10/28/2022. The study is recruiting for 482 patients at 5 locations"

Answered by AI

What are the risks associated with tisotumab vedotin?

"Tisotumab vedotin is in Phase 3 of clinical trials, so there have been multiple rounds of safety testing with some efficacy data supporting its use."

Answered by AI

How many patients are being allowed to participate in this clinical trial?

"In total, 482 individuals that meet the set inclusion criteria are required for this clinical trial. Eligible patients can choose to participate at either the University of Alberta / Cross Cancer Institute in Edmonton, Alberta or British Columbia Cancer Agency - Vancouver Centre in Vancouver, British Columbia."

Answered by AI

What therapeutic purposes does tisotumab vedotin serve?

"tisotumab vedotin can be used as both a cancer treatment and palliative care medication. It is approved to treat malignant neoplasms, unresectable thymoma, mesotheliomas, and advanced non small cell lung cancer (nsclc)."

Answered by AI
~136 spots leftby Mar 2025