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Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
Phase 1, PHASE2 trial testing avelumab in Squamous Cell Carcinoma of the Head and Neck (SCCHN) in 3 participants. Terminated before completion.
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 30 December 2019 |
| Primary completion | 29 September 2020 |
| Estimated completion | 29 September 2020 |
| Sites | 5 locations across Belgium, Spain, United States, Poland |
Pfizer — full company profile →
18 and older, any sex, with Squamous Cell Carcinoma of the Head and Neck (SCCHN) or Metastatic Castration Resistant Prostate Cancer (mCRPC). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
DLTs were graded according to NCI- CTCAE version 4.03 and coded using the latest version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) as event category and MedDRA primary system organ class (SOC) body term as Body System category.
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 1 |
Progression-Free Survival (PFS) was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. PFS data were censored on the date of the last adequate tumor assessment for participants who did not have an event (PD or death), for participants who started new anti-cancer therapy prior to an event, or for participants with an event after two or more missing tumor assessments. Participants who did not have an adequate baseline tumor assessment or who did not have any adequate post-baseline tu
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 1.69752 | 0.59913 – 1.69752 |
Overall survival (OS) was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. OS time was summarized using the Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 2.56293 | 0.59913 – NA |
Cmax was defined as the maximum observed plasma concentration at the end of infusion. Ctrough was defined as the predose concentration at the end of dosing interval.
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | NA | NA – NA |
ADA against avelumab and NKTR-214 in serum samples was determined and reported separately for ADA never-positive, ADA ever-positive participants, baseline ADA positive, treatment-boosted ADA, treatment-induced ADA, transient ADA response, persistent ADA response. For all participants, blood for ADA samples was drawn from the contralateral arm of the avelumab and NKTR-214 infusion.
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | NA |
nAb in serum samples was determined and reported separately for nAb never-positive, nAb ever-positive, baseline nAb positive, treatment-induced nAb, transient nAb response, persistent nAb response.
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | NA |
PD-L1 expression level in baseline tumor tissue, and in on-treatment tumor tissue was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and/or inflammatory cells in regions of interest. PD-L1 expression level in baseline tumor tissue and in on-treatment tumor tissue were under pathological analyses, assisted by image analysis. Participants were classified as positive or negative according to scoring algorithms and cut-offs established from internal or external sources.
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | NA |
Adverse events (AEs) were any untoward medical occurrences in a participant or clinical study participants, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment). A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that, at any dose: a. Results in dea
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 1 |
Liver Function Tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) were used to assess possible drug induced liver toxicity. The number of participants with at least one of the following laboratory results were summarized below: 1. (ALT ≥3 × ULN or AST ≥3 × ULN) post-baseline. 2. TBILI ≥2 × ULN post-baseline. 3. (ALP ≤2 × ULN or missing) post-baseline.
| Group | Value | 95% CI |
|---|---|---|
| Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | 3 |
Time frame: Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Avelumab + Bempegaldesleuk… |
|---|---|---|
| Death | General disorders | — |
| Reaction | System | Avelumab + Bempegaldesleuk… |
|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Asthenia | General disorders | — |
| Fatigue | General disorders | — |
| General physical health deterioration | General disorders | — |
| Influenza like illness | General disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count increased | Investigations | — |
| Weight decreased | Investigations | — |
| Decreased Appetite | Metabolism and nutrition disorders | — |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Hypotension | Vascular disorders | — |
Most-reported serious reactions: Death.
Data from ClinicalTrials.gov NCT04052204 adverse events section.
Evaluation of the combination of avelumab + bempegaldesleukin (NKTR-214 ) in locally advanced squamous cell carcinoma of the head and neck ( metastatic SCCHN) and avelumab + bempegaldesleukin (NKTR-214) + talazoparib or enzalutamide in metastatic castration resistant prostate cancer (mCRPC).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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