Table 2.

Studies investigating cabozantinib–IO combinations in mRCC and mUC

StudyCombinationsStudy designKey efficacy resultsKey safety results

NCT02496208 (19)

Cabozantinib + nivolumab, ± ipilimumab
  • Phase I (mUC, RCC, and other GU tumors)

  • N = 78

  • ± prior therapy

  • UC cohort: ORR 42% (8/19), 2 CR, 6 PR; median PFS: 12.8 mo (95% CI, 1.8–UN)

  • RCC cohort: ORR 54% (7/13), all PR; median PFS 18.4 mo (95% CI, 6.4–18.4)

  • All patients: Median DOR: 24.1 mo (95% CI, 14.7–UN)

  • Acceptable toxicity profile

  • Most common AEs: fatigue, diarrhea, and skin disorders

  • Immune-related AEs uncommon

CheckMate 9ER (NCT03141177)Cabozantinib + nivolumab vs. sunitinib
  • Phase III (mRCC)

  • Treatment-naïve patients

  • N = 630 (estimate)

Fully enrolled; data expected in Q1 2020

NCT03170960

Cabozantinib + Atezolizumab
  • Phase I/II (mUC, mRCC, and others)

  • N = 360 (estimate)

  • ± prior therapy

Ongoing

NCT03149822

Cabozantinib + Pembrolizumab
  • Phase I/II (mRCC)

  • N = 55 (estimate)

  • ± prior VEGF therapy

Ongoing

NCT03200587

Cabozantinib + Avelumab
  • Phase I (mRCC)

  • N = 20 (estimate)

  • Patients who are candidates for CN

Ongoing
  • Abbreviations: CN, cytoreductive nephrectomy; CR, complete response; DOR, duration of response; GU, genitourinary; IO, immuno-oncology; PR, partial response; Q1, first quarter; UN, undefined.