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New treatment option for Sub-study 1 Cervical Cancer (Volrustomig Monotherapy)
Official title Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06535607
What this study is testing
What is Volrustomig?
Volrustomig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sub-study 1 cervical cancer (volrustomig monotherapy).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 at the time of signing the ICF.
- Provision of tumor sample to assess the PD-L1 expression (if applicable).
- ECOG performance status of 0 or 1.
- Measurable disease according to RECIST 1.1 (variations of RECIST 1.1 if applicable).
- Life expectancy ≥ 12 weeks.
You likely can't join if
- Spinal cord compression.
- For sub-study 1,2,3,4, brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study...
- For sub-study 1,2,3, participants with primary neuroendocrine, mesenchymal, sarcomatoid histologies, or other histologies not mentioned as part of...
- Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy.
- For sub-study 2, have had radiotherapy within 2 weeks prior to enrollment.
- For sub-study 3,4, participants have contraindications to any of the following drugs: 5-FU, paclitaxel and carboplatin
See the full eligibility criteria
- Age ≥18 at the time of signing the ICF.
- Provision of tumor sample to assess the PD-L1 expression (if applicable).
- ECOG performance status of 0 or 1.
- Measurable disease according to RECIST 1.1 (variations of RECIST 1.1 if applicable).
- Life expectancy ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Body weight \> 35 kg
- Capable of giving signed informed consent.
- Spinal cord compression.
- For sub-study 1,2,3,4, brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. For sub-study 5, participants with untreated or progressive...
- For sub-study 1,2,3, participants with primary neuroendocrine, mesenchymal, sarcomatoid histologies, or other histologies not mentioned as part of the inclusion criteria.
- Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy.
- For sub-study 2, have had radiotherapy within 2 weeks prior to enrollment.
- For sub-study 3,4, participants have contraindications to any of the following drugs: 5-FU, paclitaxel and carboplatin
- History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence; b)...
- Any evidence of diseases, and/or history of organ transplant or allogenic stem cell transplant, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the...
- Evidence of the following infections: active infection including tuberculosis; known HIV infection. that is not well controlled; active or uncontrolled HBV or HCV; or active hepatitis A.
- History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
- Participants who are candidates for curative therapy.
- Prior exposure to any immune-mediated therapy.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids...
- For sub-study 1,2,3,4, participants are ineligible if they have received any anti-cancer therapy within 28 days prior to the first dose of study intervention or within 5 half-lives of the respective agent, whichever is...
- Any concurrent chemotherapy except study intervention, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
- Radiotherapy treatment with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention.
- Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
- Participants with a known allergy or hypersensitivity to any study intervention, on any excipients of any study intervention.
- For substudy 5: Participants with any prior systemic therapy, non-palliative radiotherapy, radical pleuropneumonectomy for pleural mesothelioma.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Clayton, Australia
- Nedlands, Australia
- Ijuí, Brazil
- Londrina, Brazil
- Natal, Brazil
- Porto Alegre, Brazil
- Santo André, Brazil
- São Caetano do Sul, Brazil
- Vitória, Brazil
- Edmonton, Alberta, Canada
- Montreal, Quebec, Canada
- Anyang, China
- Beijing, China
- Bengbu, China
+ 48 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Baltimore, Maryland, United States; New York, New York, United States; Stony Brook, New York, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States and 62 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.