EUCTR2019-001358-24-ES进行中（未招募）1 期
A Phase 1b/2 Study to Evaluate Safety and Clinical Activity of Avelumab in Combination with Bempegaldesleukin (NKTR-214) with or without Talazoparib or Enzalutamide in Participants with Locally Advanced or Metastatic Solid Tumors - JAVELIN IL-2 Medley
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 127
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •SCCHN and mCRPC
- •- >/= 18 years of age and give consent
- •- Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures as specified in the protocol
- •- Contraceptive use must meet requirements outlined in the protocol and should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •- COG of 0 or 1
- •- Participants must have adequate bone marrow function without hematopoietic growth factor or transfusion support within 14 days prior to and including C1D1 per protocol
- •- Participants must have adequate liver function by C1D1 per protocol
- •- Participants must have adequate renal function by C1D1 per protocol
- •- All participants must provide tumor tissue as described in protocol
- •Combination A- SCCHN
- •- Histological diagnosis of locally recurrent (not amenable for curative intent) or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx and both of the following:
- •- No prior systemic treatment for unresectable locally recurrent or metastatic disease
- •Exception: If prior systemic chemotherapy treatment was given as part of chemoradiotherapy treatment, disease-free interval after the last administration of systemic chemotherapy treatment must be at least 6 months
- •- Measurable disease by RECIST v1.1 with at least 1 measurable lesion
- •Combination B & C- mCRPC
- •- mCRPC without small cell features meeting the following criteria:
- •- Castration as defined by both of the following:
- •- Serum testosterone =1.73 nmol/L (50 ng/dL) at the time of enrollment (prior to treatment with study drug on C1D1)
- •- Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist/antagonist (surgical or medical castration)
- •- Progressive disease at the time of enrollment (prior to treatment with study drug on C1D1) defined as 1 or more of the following 3 criteria:
- •- A minimum of 3 consecutive rising PSA values with an interval of at least 1 week between determinations.
- •- The screening PSA value must be =2 µg/L (2 ng/mL) if qualifying solely by PSA progression
- •- Radiographic soft tissue disease progression as defined by RECIST v1.1 for soft tissue
- •- Radiographic bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic lesions on bone scan (confirm ambiguous results by other imaging modalities)
- •Combination B only (mCRPC)
- •- Progressed on at least 1 line of second generation anti-androgen therapy (e.g. enzalutamide and/or abiraterone acetate/prednisone) for treatment of mCRPC
- •- Have received at least 1, but no more than 1, prior taxane-based chemotherapy regimens for mCRPC or were deemed unsuitable, declined, or did not have access to these therapies
- •- Participants may have received radium -223, which does not count for a line of prior chemotherapy regimen
- •- Measurable disease by RECIST v1.1 with at least 1 measurable lesion
- •Phase 2 Only:
- •- Required to have their disease assessed for a genomic defect in one or more pre-defined DDR genes based on testing de novo or archival tumor tissue using the Foundation One® Test
- •Combination C only (mCRPC)
- •- Participants with non-measurable disease (including disease affecting bone only) as determined by RECIST v1.1 are allowed
- •- Participants must have progressed on 1 line of abiraterone acetate/prednisone anti-androgen therapy for treatment of mCRPC
- •- Participants must have not had any prior chemo
排除标准
- •SCCHN and mCRPC
- •- Known prior severe hypersensitivity to investigational products or any component in their formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCT CTCAE v4.03 Grade =3)
- •- Known history of: immune-mediated colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis
- •- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- •- Participants with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- •- Prior organ transplantation
- •- Vaccination within 4 weeks prior to C1D1 and while on trial is prohibited except for administration of inactivated vaccines
- •- Known symptomatic brain lesions requiring steroids
- •Exception: participants with previously diagnosed brain lesions are eligible if they meet all of the following criteria:
- •have newly diagnosed small brain lesions which do not require treatment
- •have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to C1D1
- •have discontinued corticosteroid treatment for these lesions for at least 4 weeks prior to C1D1; and are neurologically stable
- •Known history of testing positive for HIV or known AIDS
- •- Positive HBV surface antigen, or positive HCV RNA if anti-HCV antibody screening tests positive
- •- Active infection requiring systemic therapy within 14 days prior to C1D1.
- •- Other acute or chronic medical or psychiatric conditions
- •- Clinically significant (i.e., active) cardiovascular disease including the following:
- •- Documented left ventricular ejection fraction < 45%
- •- Cerebral vascular accident/stroke, Myocardial infarction (<6 months prior to C1D1)
- •- Unstable angina
- •- Congestive heart failure
- •- Serious cardiac arrhythmia requiring medication
- •- Diagnosis of any other malignancy within 2 years prior to C1D1, except for adequately treated basal cell or quamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix
- •- Prior immunotherapy with IL-2 agents or anti PD-1, anti PD-L1, anti PD-L2, or anti- CTLA-4 antibody. Prior treatment with Sipuleucel-T for participants with mCRPC is allowed
- •- Current use of immunosuppressive medication at the time of C1D1, EXCEPT for the following permitted steroids:
- •- Intranasal, inhaled, topical steroids, eye drops or local steroid injection; systemic corticosteroids at physiologic doses =10 mg/day of prednisone; steroids as premedication for hypersensitivity reactions
- •- Bisphosphonate or denosumab dosage that was not stable for at least 2 weeks before C1D1 for participants receiving these therapies
- •- Prior radiation therapy within 14 days prior to C1D1. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed > 14 days prior to C1D1 and no clinically significant toxicities are expected
- •- Major surgery within 4 weeks prior to C1D1
- •- Participation in other studies involving investigational drug(s) within 2 weeks prior to C1D1
- •- Persisting toxicity related to prior therapy (NCI CTCAE v4.03 Grade >1); however, alopecia and sensory neuropathy Grade =2, or other Grade =2 AEs not constituting a safety risk, based on Investigator's judgment (I’s), are acceptable
- •- I site staff members or participants who are Pfizer employees, directly involved in the conduct of the study and their family, site staff members otherwise supervised by the I
- •Combination A
- •- Participan
研究者
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