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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  • 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 brain metastases. - 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) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease. - 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 protocol. - 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, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control). - 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 longer. - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sub-study 1 		Volrustomig monotherapy
  • Biological: Volrustomig
    IV Infusion
Experimental
Sub-study 2 		Volrustomig monotherapy
  • Biological: Volrustomig
    IV Infusion
Experimental
Sub-study 3 Arm A 		Volrustomig in combination with carboplatin plus paclitaxel
  • Biological: Volrustomig
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Infusion
  • Drug: Paclitaxel
    IV Infusion
Experimental
Sub-study 3 Arm B 		Volrustomig in combination with carboplatin plus paclitaxel
  • Biological: Volrustomig
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Infusion
  • Drug: Paclitaxel
    IV Infusion
Experimental
Sub-study 3 Arm C 		Volrustomig in combination with 5-FU plus platinum
  • Biological: Volrustomig
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Infusion
  • Drug: 5-FU
    IV Infusion
Experimental
Sub-study 4 Arm A 		Volrustomig in combination with cisplatin + 5-FU
  • Biological: Volrustomig
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: 5-FU
    IV Infusion
Experimental
Sub-study 4 Arm B 		Volrustomig in combination with cisplatin + paclitaxel
  • Biological: Volrustomig
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Paclitaxel
    IV Infusion
Experimental
Sub-study 5 		Volrustomig monotherapy
  • Biological: Volrustomig
    IV Infusion

Recruiting Locations

Research Site
Baltimore, Maryland 21201

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
+18772409479
information.center@astrazeneca.com

Detailed Description

eVOLVE-02 study will evaluate volrustomig monotherapy or volrustomig-based combination therapy in various advanced or metastatic solid tumors. In sub-study 1, volrustomig will be evaluated as monotherapy in approximately 30 evaluable participants with cervical cancer. In sub-study 2, volrustomig will be evaluated as monotherapy in approximately 20 evaluable participants with head and neck squamous cell carcinoma. In sub-study 3, Volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with head and neck squamous cell carcinoma. In sub-study 4, volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with esophagus squamous cell carcinoma. In sub-study 5, volrustomig will be evaluated as monotherapy in approximately 75 evaluable participants with unresectable pleural mesothelioma.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.