Renal Cell Carcinoma (RCC)Phase 1STELLAR-002NCT05176483
Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors
A Phase 1 study testing Zanzalintinib, Nivolumab and Ipilimumab in people with Renal Cell Carcinoma (RCC) and Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Exelixis at 122 sites in 13 countries.
Trial summary
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Urothelial Carcinoma (UC)
- What is being tested?
- Zanzalintinib, Nivolumab and Ipilimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,394 participants
- Where
- 122 sitesin 13 countries
- Study dates
- 14 Dec 2021to 28 Jun 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.
- Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.
- Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.
- Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.
- Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.
- Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)/Programmed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.
Show all 37Show fewer
- Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.
- Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.
- Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.
- Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).
- Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence < 12 months from the end of last therapy.
- Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.
- Expansion Cohort 5 (post enfortumab vedotin [EV] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.
- Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1/PD-L1 inhibitor or ineligible for PD-1/PD-L1 inhibitor.
- Prior receipt of platinum-based therapy allowed but not required.
- Prior therapy with other agents allowed but not required.
- Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.
- No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.
- Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and/or unresectable HCC that is not amenable to curative treatment or locoregional therapy.
- Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score [TPS] 1-49%) and without prior systemic anticancer therapy for metastatic disease.
- Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.
- Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.
- Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.
- Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.
- Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma
- Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.
- Cohort 15 (mCRPC, post-ARPI, visceral metastases): Men with metastatic adenocarcinoma of the prostate.
- Cohort 16 (Drug-drug interaction [DDI]):
- Participants with a solid tumor that is unresectable or metastatic and for which life prolonging therapies do not exist or available therapies are intolerable or no longer effective.
- Able to swallow capsules or tablets.
- For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.
- For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
- Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
- Karnofsky Performance Status (KPS) ≥ 70%.
- Adequate organ and marrow function.
- Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.
- Females of childbearing potential must not be pregnant at screening.
Who cannot join
- For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1/PD-L1, Lymphocyte-activation gene 3 (LAG-3) and cytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).
- For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
- For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
- For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.
- Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
- Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.
Show all 37Show fewer
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
- Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.
- Administration of a live, attenuated vaccine within 30 days prior to first dose.
- Uncontrolled, significant intercurrent or recent illness.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms for females and > 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.
- Participants with inadequately treated adrenal insufficiency.
- Pregnant or lactating females.
- Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.
- For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.
- For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.
- For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.
- For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.
- For Cohort 7 (HCC):
- Documented hepatic encephalopathy (HE) within 6 months before the first dose.
- Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.
- Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.
- Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma
- For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and/or trifluridine + tipiracil (TAS-102).
- For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.
- For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable [MSS], 2L+), and 11 (HNSCC):
- Troponin T (TnT) or I (TnI) > 2 × institutional upper limit of normal (ULN).
- For Cohort 16 (DDI):
- Known hypersensitivity to midazolam, warfarin, omeprazole, or caffeine.
- History of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within 3 months prior to first dose of study treatment on Day 1.
- Primary liver tumor.
- Unable to refrain from or anticipates the use of the following:
- Any drugs known to be inducers or inhibitors of CYP3A4, CYP2C9, CYP2C19, and/or CYP1A2 within 14 days before the first dose of study treatment on Day 1 through the DDI assessments on Day 20.
- Drugs that are contraindicated with midazolam, warfarin, omeprazole, and/or caffeine during the DDI assessment part.
- Caffeine-containing beverages, products, and foods at least 3 days prior to and 3 days after probe substrate cocktail administration on Day 1 and Day 16.
- Poor peripheral venous access.
- Note: Additional Inclusion and Exclusion criteria may apply.
Trial locations and contacts
122 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
Backup or International contact
122 sites in 13 countries
United States46 sites, 39 recruiting
- Recruiting
Exelixis Clinical Site #46
Austin, Texas, 78705
- Recruiting
Exelixis Clinical Site #14
Baltimore, Maryland, 21201
- Recruiting
Exelixis Clinical Site #7
Boston, Massachusetts, 02215
- Recruiting
Exelixis Clinical Site #48
Celebration, Florida, 34747
- Recruiting
Exelixis Clinical Site #66
Charlottesville, Virginia, 22903
- Recruiting
Exelixis Clinical Site #26
Chicago, Illinois, 60612
- Recruiting
Exelixis Clinical Site #10
Cleveland, Ohio, 44106
- Withdrawn
Exelixis Clinical Site #111
Dallas, Texas, 75246
- Recruiting
Exelixis Clinical Site #89
Dallas, Texas, 75246
- Recruiting
Exelixis Clinical Site #65
Detroit, Michigan, 48201
- Recruiting
Exelixis Clinical Site #13
Detroit, Michigan, 48202
- Recruiting
Exelixis Clinical Site #12
Durham, North Carolina, 27710
- Recruiting
Exelixis Clinical Site #88
East Brunswick, New Jersey, 08816
- Recruiting
Exelixis Clinical Site #11
Gainesville, Florida, 32610
- Recruiting
Exelixis Clinical Site #105
Hackensack, New Jersey, 07601
- Recruiting
Exelixis Clinical Site #104
Hershey, Pennsylvania, 17033
- Recruiting
Exelixis Clinical Site #4
Indianapolis, Indiana, 46250
- Recruiting
Exelixis Clinical Site #73
Irving, Texas, 75063
- Recruiting
Exelixis Clinical Site #78
Jacksonville, Florida, 32224
- Recruiting
Exelixis Clinical Site #55
Las Vegas, Nevada, 89052
- Recruiting
Exelixis Clinical Site #87
Littleton, Colorado, 80124
- Withdrawn
Exelixis Clinical Site #122
Louisville, Kentucky, 40202
- Recruiting
Exelixis Clinical Site #47
Miami, Florida, 33136
- Recruiting
Exelixis Clinical Site #33
Milwaukee, Wisconsin, 53226
- Recruiting
Exelixis Clinical Site #9
Myrtle Beach, South Carolina, 29572
- Recruiting
Exelixis Clinical Site #3
Nashville, Tennessee, 37203
- Recruiting
Exelixis Clinical Site #62
New Haven, Connecticut, 06510
- Recruiting
Exelixis Clinical Site #60
New York, New York, 10032
- Recruiting
Exelixis Clinical Site #6
New York, New York, 10065
- Active, not recruiting
Exelixis Clinical Site #49
Newark, Delaware, 19713
- Recruiting
Exelixis Clinical Site #2
Omaha, Nebraska, 68130
- Active, not recruiting
Exelixis Clinical Site #5
Omaha, Nebraska, 68130
- Completed
Exelixis Clinical Site #123
Palo Alto, California, 94304
- Recruiting
Exelixis Clinical Site #98
Philadelphia, Pennsylvania, 19104
- Recruiting
Exelixis Clinical Site #67
Phoenix, Arizona, 85054
- Recruiting
Exelixis Clinical Site #32
Pittsburgh, Pennsylvania, 15212
- Completed
Exelixis Clinical Site #24
Pittsburgh, Pennsylvania, 15232
- Recruiting
Exelixis Clinical Site #50
Plano, Texas, 75075
- Withdrawn
Exelixis Clinical Site #61
Plantation, Florida, 33322
- Recruiting
Exelixis Clinical Site #51
Portland, Oregon, 97239
- Recruiting
Exelixis Clinical Site #68
Rochester, Minnesota, 55905
- Recruiting
Exelixis Clinical Site #59
Santa Barbara, California, 93463
- Recruiting
Exelixis Clinical Site #76
Syracuse, New York, 13210
- Recruiting
Exelixis Clinical Site #8
Tampa, Florida, 33612
- Recruiting
Exelixis Clinical Site #1
Tucson, Arizona, 85711
- Recruiting
Exelixis Clinical Site #70
Tyler, Texas, 75601
Spain16 sites, 15 recruiting
- Recruiting
Exelixis Clinical Site #41
Badajoz, 06080
- Recruiting
Exelixis Clinical Site #53
Barcelona, 08035
- Recruiting
Exelixis Clinical Site #15
Barcelona, 08036
- Recruiting
Exelixis Clinical Site #27
Barcelona, 08041
- Withdrawn
Exelixis Clinical Site #120
L'Hospitalet de Llobregat, 08908
- Recruiting
Exelixis Clinical Site #57
Madrid, 28033
- Recruiting
Exelixis Clinical Site #43
Madrid, 28034
- Recruiting
Exelixis Clinical Site #58
Madrid, 28040
- Recruiting
Exelixis Clinical Site #77
Madrid, 28040
- Recruiting
Exelixis Clinical Site #19
Madrid, 28041
- Recruiting
Exelixis Clinical Site #100
Madrid, 28046
- Recruiting
Exelixis Clinical Site #18
Pamplona, 31008
- Recruiting
Exelixis Clinical Site #119
Santander, 39008
- Recruiting
Exelixis Clinical Site #23
Seville, 41013
- Recruiting
Exelixis Clinical Site #56
Valencia, 46010
- Recruiting
Exelixis Clinical Site #25
Valencia, 46026
France14 sites, 11 recruiting
- Recruiting
Exelixis Clinical Site #85
Besançon, 25030
- Recruiting
Exelixis Clinical Site #96
Bordeaux, 33000
- Recruiting
Exelixis Clinical Site #79
Caen, 14076
- Recruiting
Exelixis Clinical Site #118
Clermont-Ferrand, 63011
- Withdrawn
Exelixis Clinical Site #109
Lyon, 69008
- Recruiting
Exelixis Clinical Site #92
Marseille, 13273
- Recruiting
Exelixis Clinical Site #64
Nice, 06189
- Recruiting
Exelixis Clinical Site #83
Paris, 75010
- Withdrawn
Exelixis Clinical Site #91
Paris, 75015
- Recruiting
Exelixis Clinical Site #80
Rennes, 35042
- Recruiting
Exelixis Clinical Site #63
Saint-Herblain, 44805
- Completed
Exelixis Clinical Site #75
Strasbourg, 67200
- Recruiting
Exelixis Clinical Site #84
Vandœuvre-lès-Nancy, 54519
- Recruiting
Exelixis Clinical Site #115
Villejuif, 94805
Germany9 sites, 5 recruiting
- Recruiting
Exelixis Clinical Site #103
Essen, 45147
- Withdrawn
Exelixis Clinical Site #113
Hamburg, 22763
- Recruiting
Exelixis Clinical Site #108
Heidelberg, 69120
- Completed
Exelixis Clinical Site #82
Herne, 44625
- Recruiting
Exelixis Clinical Site #93
Jena, 07747
- Completed
Exelixis Clinical Site #112
München, 81737
- Recruiting
Exelixis Clinical Site #102
Nürtingen, 72622
- Withdrawn
Exelixis Clinical Site #107
Trier, 54292
- Recruiting
Exelixis Clinical Site #95
Tübingen, 72076
Italy7 sites, 6 recruiting
- Recruiting
Exelixis Clinical Site #121
Ancona, 60020
- Recruiting
Exelixis Clinical Site #117
Bologna, 40138
- Recruiting
Exelixis Clinical Site #90
Florence, 50134
- Withdrawn
Exelixis Clinical Site #101
Milan, 20132
- Recruiting
Exelixis Clinical Site #81
Milan, 20141
- Recruiting
Exelixis Clinical Site #40
Naples, 80131
- Recruiting
Exelixis Clinical Site #74
Ravenna, 48121
Israel6 sites, 5 recruiting
- Recruiting
Exelixis Clinical Site #86
Beersheba, 8410101
- Recruiting
Exelixis Clinical Site #72
Haifa, 3109601
- Withdrawn
Exelixis Clinical Site #52
Jerusalem, 9112001
- Recruiting
Exelixis Clinical Site #71
Petah Tikva, 4941492
- Recruiting
Exelixis Clinical Site #69
Tel Aviv, 6423906
- Recruiting
Exelixis Clinical Site #38
Ẕerifin, 7030000
Australia5 sites, 4 recruiting
- Withdrawn
Exelixis Clinical Site #116
Albury, 2640
- Recruiting
Exelixis Clinical Site #35
Birtinya, 4575
- Recruiting
Exelixis Clinical Site #16
Brisbane, 4102
- Recruiting
Exelixis Clinical Site #42
Saint Leonards, 2065
- Recruiting
Exelixis Clinical Site #36
Sydney, 2109
Poland5 sites, 5 recruiting
- Recruiting
Exelixis Clinical Site #20
Bydgoszcz, 85-796
- Recruiting
Exelixis Clinical Site #28
Gdansk, 80-219
- Recruiting
Exelixis Clinical Site #34
Otwock, 05-400
- Recruiting
Exelixis Clinical Site #54
Poznan, 60-569
- Recruiting
Exelixis Clinical Site #114
Wroclaw, 53-413
Austria4 sites, 3 recruiting
- Recruiting
Exelixis Clinical Site #94
Graz, 8036
- Completed
Exelixis Clinical Site #31
Salzburg, 5020
- Recruiting
Exelixis Clinical Site #29
Vienna, 1020
- Recruiting
Exelixis Clinical Site #106
Wein, 1090
Switzerland3 sites, 2 recruiting
- Completed
Exelixis Clinical Site #21
Chur, 7000
- Recruiting
Exelixis Clinical Site #22
Sankt Gallen, 9007
- Recruiting
Exelixis Clinical Site #44
Winterthur, 8401
United Kingdom3 sites, 3 recruiting
- Recruiting
Exelixis Clinical Site #110
Cambridge, CB2 0QQ
- Recruiting
Exelixis Clinical Site #99
London, W6 8RF
- Recruiting
Exelixis Clinical Site #97
Middlesex, HA6 2RN
Belgium2 sites, 1 recruiting
- Completed
Exelixis Clinical Site #39
Anderlecht, 1070
- Recruiting
Exelixis Clinical Site #37
Kortrijk, 8500
New Zealand2 sites, 2 recruiting
- Recruiting
Exelixis Clinical Site #30
Grafton, 1023
- Recruiting
Exelixis Clinical Site #45
Hamilton, 3204
About this study
Official title: A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology or Other Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates in participants with advanced solid tumors.
In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
- Conditions
- Renal Cell Carcinoma (RCC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Urothelial Carcinoma (UC), Solid Tumor, Hepatocellular Carcinoma (HCC), Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Zanzalintinib, Nivolumab, Ipilimumab, Nivolumab + Relatlimab, Prednisone
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanzalintinibDrug
Also called XL092
Zanzalintinib orally once daily (qd)
NivolumabDrug
Also called Opdivo
360 mg intravenous (IV) infusion once every 3 weeks (q3w)
IpilimumabDrug
Also called Yervoy
1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses
Nivolumab + RelatlimabDrug
IV administration of nivolumab + relatlimab
PrednisoneDrug
Administered as IV infusion.
DocetaxelDrug
Administered as oral tablet.
DDI Probe CocktailDrug
Midazolam, Warfarin, Omeprazole, and Caffeine administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Zanzalintinib + Nivolumab Dose-Escalation Cohorts | Experimental | Approximately 12 participants will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design. Receives: Drug: Zanzalintinib; Drug: Nivolumab |
| Zanzalintinib + Nivolumab + Ipilimumab Dose-Escalation Cohorts | Experimental | Approximately 12 participants will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design. Receives: Drug: Zanzalintinib; Drug: Nivolumab; Drug: Ipilimumab |
| Zanzalintinib + Nivolumab Expansion Cohorts | Experimental | The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts. Receives: Drug: Zanzalintinib; Drug: Nivolumab |
| Zanzalintinib + Nivolumab + Ipilimumab Expansion Cohorts | Experimental | The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts. Receives: Drug: Zanzalintinib; Drug: Nivolumab; Drug: Ipilimumab |
| Zanzalintinib Single-Agent Expansion Cohorts | Experimental | Not described Receives: Drug: Zanzalintinib |
| Zanzalintinib + Nivolumab + Relatlimab Dose-Escalation Cohorts | Experimental | Approximately 12 participants will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design. Receives: Drug: Zanzalintinib; Drug: Nivolumab + Relatlimab |
| Zanzalintinib + Nivolumab + Relatlimab Expansion Cohorts | Experimental | The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts. Receives: Drug: Zanzalintinib; Drug: Nivolumab + Relatlimab |
| Zanzalintinib + Docetaxel + Prednisone Dose Expansion Cohort | Experimental | Participants with mCRPC, post-androgen receptor pathway inhibitor (post-ARPI), visceral metastases. The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts. Receives: Drug: Zanzalintinib; Drug: Prednisone; Drug: Docetaxel |
| Zanzalintinib + DDI Probe Substrates Dose Expansion Cohort | Experimental | Participants in the DDI Cohort. The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts. Receives: Drug: Zanzalintinib; Drug: DDI Probe Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Including Immune-Mediated Adverse Events (imAEs)
Measured: Up to 36 months
Expansion Stage (All Cohorts Except Cohort 15 [mCRPC, post-ARPI, visceral metastases] and Cohort 16 [DDI]): Objective Response Rate (ORR)
As assessed by the Investigator per Response Evaluation Criteria in Solid Tumors guideline version 1.1 (RECIST 1.1).
Measured: Up to 24 months
Expansion Stage Cohort 3 (mCRPC, post 1 NHT): Progression-Free Survival (PFS)
As assessed by the Investigator per RECIST 1.1.
Measured: Up to 24 months
Expansion Stage Cohort 10 (CRC): Overall Survival (OS)
Measured: 6 months
Expansion Stage Cohort 15 (mCRPC, Post-ARPI, Visceral Metastases): PFS-6 (Six Month PFS)
As assessed by the Investigator per RECIST 1.1.
Measured: 6 months
Expansion Stage Cohort 16 (DDI): Area Under the Concentration-Versus-Time Curve (AUC) of Each DDI Probe Substrate With and Without Zanzalintinib
Measured: Predose upto 8 hours postdose
Expansion Stage Cohort 16 (DDI): Maximum Concentration (Cmax) of Each DDI Probe Substrate With and Without Zanzalintinib
Measured: Predose upto 8 hours postdose
Secondary outcomes (7)
Expansion Stage (All Cohorts Except Cohort 16 [DDI]): Duration of Response (DOR)
To evaluate DOR in participants with measurable disease as assessed by the Investigator per RECIST 1.1.
Measured: Up to 24 months
Expansion Stage (All Cohorts Except Cohort 16 [DDI]): Progression-Free Survival (PFS)
As assessed by the Investigator per RECIST 1.1.
Measured: Up to 24 months
Expansion Stage Cohort 15 (mCRPC, Post-ARPI, Visceral Metastases): PFS-12 (12 Month PFS)
As assessed by the Investigator per RECIST 1.1.
Measured: 12 months
Expansion Stage Cohort 15 (mCRPC, Post-ARPI, Visceral Metastases): Prostate-Specific Antigen 50% Response Rate (PSA50-RR)
Measured: Up to 24 months
Expansion Stage Cohort 15 (mCRPC, Post-ARPI, Visceral Metastases): ORR
As assessed by the Investigator per RECIST 1.1.
Measured: 12 months
Expansion Stage Cohort 15 (mCRPC, Post-ARPI, Visceral Metastases): AUC of Zanzalintinib
Measured: Predose upto 8 hours postdose
Expansion Stage Cohort 15 (mCRPC, Post-ARPI, Visceral Metastases): AUC of Docetaxel
Measured: Predose upto 8 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start14 Dec 2021
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by ExelixisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose-escalation followed by expansion phase with parallel assignment.
- Masking
- None (open label)
- Enrolment
- 1,394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176483
- Sponsor's protocol ID
- XL092-002
- Other IDs
- 2023-510061-10-00, 2023
- Acronym
- STELLAR-002
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No